Review

.2023 Oct 9;10(10):CD011769.

doi: 10.1002/14651858.CD011769.pub2.

Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD)

Michelle Iffland¹, Nuala Livingstone², Mikaela Jorgensen¹, Philip Hazell³, Donna Gillies^{1 4}

Affiliations

PMID:37811711
PMCID: PMC10561353
DOI: 10.1002/14651858.CD011769.pub2

Review

Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD)

Michelle Iffland et al. Cochrane Database Syst Rev.2023.

.2023 Oct 9;10(10):CD011769.

doi: 10.1002/14651858.CD011769.pub2.

Authors

Michelle Iffland¹, Nuala Livingstone², Mikaela Jorgensen¹, Philip Hazell³, Donna Gillies^{1 4}

Affiliations

¹ Senior Practitioner Branch, NDIS Quality and Safeguards Commission, Penrith, Australia.
² Cochrane Evidence Production and Methods Directorate , Cochrane, London, UK.
³ Speciality of Psychiatry, University of Sydney School of Medicine, Sydney, Australia.
⁴ Sydney, Australia.

PMID:37811711
PMCID: PMC10561353
DOI: 10.1002/14651858.CD011769.pub2

Abstract

Background: Pharmacological interventions are frequently used for people with autism spectrum disorder (ASD) to manage behaviours of concern, including irritability, aggression, and self-injury. Some pharmacological interventions might help treat some behaviours of concern, but can also have adverse effects (AEs).

Objectives: To assess the effectiveness and AEs of pharmacological interventions for managing the behaviours of irritability, aggression, and self-injury in ASD.

Search methods: We searched CENTRAL, MEDLINE, Embase, 11 other databases and two trials registers up to June 2022. We also searched reference lists of relevant studies, and contacted study authors, experts and pharmaceutical companies.

Selection criteria: We included randomised controlled trials of participants of any age with a clinical diagnosis of ASD, that compared any pharmacological intervention to an alternative drug, standard care, placebo, or wait-list control.

Data collection and analysis: We used standard Cochrane methods. Primary outcomes were behaviours of concern in ASD, (irritability, aggression and self-injury); and AEs. Secondary outcomes were quality of life, and tolerability and acceptability. Two review authors independently assessed each study for risk of bias, and used GRADE to judge the certainty of the evidence for each outcome.

Main results: We included 131 studies involving 7014 participants in this review. We identified 26 studies as awaiting classification and 25 as ongoing. Most studies involved children (53 studies involved only children under 13 years), children and adolescents (37 studies), adolescents only (2 studies) children and adults (16 studies), or adults only (23 studies). All included studies compared a pharmacological intervention to a placebo or to another pharmacological intervention. Atypical antipsychotics versus placebo At short-term follow-up (up to 6 months), atypical antipsychotics probably reduce irritability compared to placebo (standardised mean difference (SMD) -0.90, 95% confidence interval (CI) -1.25 to -0.55, 12 studies, 973 participants; moderate-certainty evidence), which may indicate a large effect. However, there was no clear evidence of a difference in aggression between groups (SMD -0.44, 95% CI -0.89 to 0.01; 1 study, 77 participants; very low-certainty evidence). Atypical antipsychotics may also reduce self-injury (SMD -1.43, 95% CI -2.24 to -0.61; 1 study, 30 participants; low-certainty evidence), possibly indicating a large effect. There may be higher rates of neurological AEs (dizziness, fatigue, sedation, somnolence, and tremor) in the intervention group (low-certainty evidence), but there was no clear evidence of an effect on other neurological AEs. Increased appetite may be higher in the intervention group (low-certainty evidence), but we found no clear evidence of an effect on other metabolic AEs. There was no clear evidence of differences between groups in musculoskeletal or psychological AEs. Neurohormones versus placebo At short-term follow-up, neurohormones may have minimal to no clear effect on irritability when compared to placebo (SMD -0.18, 95% CI -0.37 to -0.00; 8 studies; 466 participants; very low-certainty evidence), although the evidence is very uncertain. No data were reported for aggression or self -injury. Neurohormones may reduce the risk of headaches slightly in the intervention group, although the evidence is very uncertain. There was no clear evidence of an effect of neurohormones on any other neurological AEs, nor on any psychological, metabolic, or musculoskeletal AEs (low- and very low-certainty evidence). Attention-deficit hyperactivity disorder (ADHD)-related medications versus placebo At short-term follow-up, ADHD-related medications may reduce irritability slightly (SMD -0.20, 95% CI -0.40 to -0.01; 10 studies, 400 participants; low-certainty evidence), which may indicate a small effect. However, there was no clear evidence that ADHD-related medications have an effect on self-injury (SMD -0.62, 95% CI -1.63 to 0.39; 1 study, 16 participants; very low-certainty evidence). No data were reported for aggression. Rates of neurological AEs (drowsiness, emotional AEs, fatigue, headache, insomnia, and irritability), metabolic AEs (decreased appetite) and psychological AEs (depression) may be higher in the intervention group, although the evidence is very uncertain (very low-certainty evidence). There was no evidence of a difference between groups for any other metabolic, neurological, or psychological AEs (very low-certainty evidence). No data were reported for musculoskeletal AEs. Antidepressants versus placebo At short-term follow-up, there was no clear evidence that antidepressants have an effect on irritability (SMD -0.06, 95% CI -0.30 to 0.18; 3 studies, 267 participants; low-certainty evidence). No data for aggression or self-injury were reported or could be included in the analysis. Rates of metabolic AEs (decreased energy) may be higher in participants receiving antidepressants (very low-certainty evidence), although no other metabolic AEs showed clear evidence of a difference. Rates of neurological AEs (decreased attention) and psychological AEs (impulsive behaviour and stereotypy) may also be higher in the intervention group (very low-certainty evidence) although the evidence is very uncertain. There was no clear evidence of any difference in the other metabolic, neurological, or psychological AEs (very low-certainty evidence), nor between groups in musculoskeletal AEs (very low-certainty evidence). Risk of bias We rated most of the studies across the four comparisons at unclear overall risk of bias due to having multiple domains rated as unclear, very few rated as low across all domains, and most having at least one domain rated as high risk of bias.

Authors' conclusions: Evidence suggests that atypical antipsychotics probably reduce irritability, ADHD-related medications may reduce irritability slightly, and neurohormones may have little to no effect on irritability in the short term in people with ASD. There was some evidence that atypical antipsychotics may reduce self-injury in the short term, although the evidence is uncertain. There was no clear evidence that antidepressants had an effect on irritability. There was also little to no difference in aggression between atypical antipsychotics and placebo, or self-injury between ADHD-related medications and placebo. However, there was some evidence that atypical antipsychotics may result in a large reduction in self-injury, although the evidence is uncertain. No data were reported (or could be used) for self-injury or aggression for neurohormones versus placebo. Studies reported a wide range of potential AEs. Atypical antipsychotics and ADHD-related medications in particular were associated with an increased risk of metabolic and neurological AEs, although the evidence is uncertain for atypical antipsychotics and very uncertain for ADHD-related medications. The other drug classes had minimal or no associated AEs.

Trial registration: ClinicalTrials.govNCT00872898 NCT00490802 NCT00773812 NCT00873509 NCT01333072 NCT01227668 NCT00844753 NCT01592747 NCT00380692 NCT00515320 NCT00004486 NCT00211757 NCT01040221 NCT01617447 NCT00576732 NCT00086645 NCT02552147 NCT01911442 NCT00005014 NCT01086475 NCT00183339 NCT00198107 NCT00468130 NCT00498173 NCT01337687 NCT01624675 NCT01908205 NCT01972074 NCT02940574 NCT00365859 NCT01624194 NCT01962870 NCT00178503 NCT00025779 NCT01238575 NCT01944046 NCT01793441 NCT00065962 NCT00453180 NCT01098383 NCT00057408 NCT00198120 NCT01914939 NCT01970345 NCT03553875 NCT04520685 NCT03887676.

PubMed Disclaimer

Conflict of interest statement

Michelle Iffland is a Research Officer with the NDIS Quality and Safeguards Commission, NSW. The NDIS Quality and Safeguards Commission is committed to reducing and eliminating the use of restrictive practices in people with a disability.

Donna Gillies is the Director for Research and Practice Evidence with the NDIS Quality and Safeguards Commission, Penrith, NSW. The NDIS Quality and Safeguards Commission is committed to reducing and eliminating the use of restrictive practices in people with a disability.

Nuala Livingstone is a Quality Assurance Editor with the Cochrane Evidence Production and Methods Directorate, Central Editorial Service, and an Editor with Cochrane Developmental, Psychosocial and Developmental Problems (DPLP); UK. Nuala Livingstone was not involved in the editorial process for this article

Mikaela Jorgensen is the Assistant Director of Research with the NDIS Quality and Safeguards Commission, NSW, which is committed to the reduction and elimination of restrictive practices for people with disability.

Philip Hazell (PH) reports payments for lectures, for Lilly, Janssen, Pfizer and Shire, and advisory boards for Lilly, Janssen and Shire related to the pharmacological management of child and adolescent mental disorders in general; paid to Sydney Local Health District; PH is a Consultant Psychiatrist for Sydney Local Health District, NSW, and an Editor with Cochrane Developmental, Psychosocial and Learning Problems, UK. PH reports being involved in a study eligible for inclusion in this review:Multisite randomised control trail of fluoxetine for children and adolescents with autism; the study was funded by NHMRC and hosted by Murdoch Children's Research Institute, VIC. The researchers retained complete control over the study design, methods, data analysis and reporting. PH was not involved in assessing the studies for eligibility, extracting data from the studies, or assessing the risk of bias or grading the certainty of the evidence; these methods were completed by two independent review authors (DG, MI, MJ, NL).

Figures

4
Visual representation of risk of bias across all included studies

5
**SE:** standard error;**SMD:** standardised mean difference Atypical antipsychotics versus placebo (12 studies, 973 participants; Analysis 1.1)

6
**log:** logarithm;**SE:** standard error;**RR:** risk ratio Atypical antipsychotics versus placebo (8 studies, 702 participants; Analysis 1.9)

7
**log:** logarithm;**RR:** risk ratio;**SE:** standard error;**SMD:** standardised mean difference Atypical antipsychotics versus placebo (11 studies, 974 participants; Analysis 1.12)

8
**log:** logarithm;**RR:** risk ratio;**SE:** standard error;**SMD:** standardised mean difference Neurohormone versus placebo (10 studies, 863 participants; Analysis 2.9)

9
**log:** logarithm;**RR:** risk ratio;**SE:** standard error;**SMD:** standardised mean difference Antidepressant versus placebo (4 studies, 243 participants; Analysis 4.7)

10
**log:** logarithm;**RR:** risk ratio;**SE:** standard error;**SMD:** standardised mean difference Antidepressant versus placebo (4 studies, 243 participants; Analysis 4.8)

**1.1. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 1: Irritability

**1.2. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 2: Relapse

**1.3. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 3: Improvement

**1.4. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 4: Aggression

**1.5. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 5: Self‐injury

**1.6. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 6: Adverse effects: cardiovascular

**1.7. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 7: Adverse effects: gastrointestinal

**1.8. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 8: Adverse effects: immune system

**1.9. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 9: Adverse effects: metabolic (dichotomous)

**1.10. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 10: Adverse effects: metabolic (continuous)

**1.11. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 11: Adverse effects: musculoskeletal

**1.12. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 12: Adverse effects: neurological

**1.13. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 13: Adverse effects: psychological

**1.14. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 14: Adverse effects: respiratory

**1.15. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 15: Adverse effects: skin

**1.16. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 16: Adverse effects: urinary

**1.17. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 17: Quality of life

**1.18. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 18: Tolerability/acceptability: loss to follow‐up

**1.19. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 19: Subgroup analysis: age ‐ irritability

**1.20. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 20: Subgroup analysis: age ‐ aggression

**1.21. Analysis**
Comparison 1: Atypical antipsychotic vs placebo, Outcome 21: Subgroup analysis: cognitive ability ‐ irritability

**2.1. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 1: Irritability

**2.2. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 2: Self‐injury

**2.3. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 3: Adverse effects: cardiovascular

**2.4. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 4: Adverse effects: gastrointestinal

**2.5. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 5: Adverse effects: immune system

**2.6. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 6: Adverse effects: metabolic (dichotomous)

**2.7. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 7: Adverse effects: metabolic (continuous)

**2.8. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 8: Adverse effects: musculoskeletal

**2.9. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 9: Adverse effects: neurological

**2.10. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 10: Adverse effects: psychological

**2.11. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 11: Adverse effects: respiratory

**2.12. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 12: Adverse effects: skin

**2.13. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 13: Adverse effects: urinary

**2.14. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 14: Adverse effects: other

**2.15. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 15: Quality of life

**2.16. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 16: Tolerability/acceptability: loss to follow‐up

**2.17. Analysis**
Comparison 2: Neurohormone versus placebo, Outcome 17: Subgroup analyses: gender ‐ irritability

**3.1. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 1: Irritability

**3.2. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 2: Self‐injury

**3.3. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 3: Adverse effects: cardiovascular

**3.4. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 4: Adverse effects: gastrointestinal

**3.5. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 5: Adverse effects: immune system

**3.6. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 6: Adverse effects: metabolic (dichotomous)

**3.7. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 7: Adverse effects: neurological (dichotomous)

**3.8. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 8: Adverse effects: neurological (continuous)

**3.9. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 9: Adverse effects: psychological (dichotomous)

**3.10. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 10: Adverse effects: respiratory

**3.11. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 11: Adverse effects: skin

**3.12. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 12: Adverse effects: urinary

**3.13. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 13: Quality of life

**3.14. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 14: Tolerability/acceptability: loss to follow‐up

**3.15. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 15: Subgroup analyses: gender ‐ irritability

**3.16. Analysis**
Comparison 3: ADHD‐related medications vs placebo, Outcome 16: Subgroup analyses: age ‐ irritability

**4.1. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 1: Irritability

**4.2. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 2: Adverse effects: cardiovascular

**4.3. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 3: Adverse effects: gastrointestinal

**4.4. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 4: Adverse effect: immune system

**4.5. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 5: Adverse effects: metabolic

**4.6. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 6: Adverse effect: musculoskeletal

**4.7. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 7: Adverse effects: neurological

**4.8. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 8: Adverse effects: psychological

**4.9. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 9: Adverse effects: respiratory

**4.10. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 10: Adverse effects: skin

**4.11. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 11: Adverse effects: urinary

**4.12. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 12: Adverse effects: other

**4.13. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 13: Tolerability/acceptability: loss to follow‐up

**4.14. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 14: Subgroup analyses: gender ‐ irritability

**4.15. Analysis**
Comparison 4: Antidepressant vs placebo, Outcome 15: Serious adverse events

**5.1. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 1: Irritability

**5.2. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 2: Adverse effects: cardiovascular (tachycardia)

**5.3. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 3: Adverse effects: gastrointestinal

**5.4. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 4: Adverse effects: metabolic (dichotomous)

**5.5. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 5: Adverse effects: metabolic (continuous)

**5.6. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 6: Adverse effects: neurological

**5.7. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 7: Adverse effects: respiratory

**5.8. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 8: Adverse effects: skin

**5.9. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 9: Adverse effects: urinary

**5.10. Analysis**
Comparison 5: Atypical vs typical antipsychotics, Outcome 10: Tolerability/acceptability: loss to follow‐up

**6.1. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 1: Irritability

**6.2. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 2: Adverse effects: cardiovascular

**6.3. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 3: Adverse effects: gastrointestinal

**6.4. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 4: Adverse effects: metabolic

**6.5. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 5: Adverse effects: musculoskeletal

**6.6. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 6: Adverse effects: neurological

**6.7. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 7: Adverse effects: psychological

**6.8. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 8: Adverse effects: skin

**6.9. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 9: Adverse effects: urinary

**6.10. Analysis**
Comparison 6: Atypical vs atypical antipsychotics, Outcome 10: Tolerability/acceptability: loss to follow‐up

**7.1. Analysis**
Comparison 7: Atypical antipsychotic vs antidementia, Outcome 1: Irritability

**7.2. Analysis**
Comparison 7: Atypical antipsychotic vs antidementia, Outcome 2: Adverse effects: neurological

**7.3. Analysis**
Comparison 7: Atypical antipsychotic vs antidementia, Outcome 3: Tolerability

**8.1. Analysis**
Comparison 8: Atypical antipsychotic vs antiparkinsonian, Outcome 1: Adverse effects: gastrointestinal

**8.2. Analysis**
Comparison 8: Atypical antipsychotic vs antiparkinsonian, Outcome 2: Adverse effects: metabolic

**8.3. Analysis**
Comparison 8: Atypical antipsychotic vs antiparkinsonian, Outcome 3: Adverse effects: neurological

**9.1. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 1: Irritability

**9.2. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 2: Aggression

**9.3. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 3: Adverse effects: gastrointestinal

**9.4. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 4: Adverse effects: immune system

**9.5. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 5: Adverse effects: metabolic (dichotomous)

**9.6. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 6: Adverse effects: metabolic (continuous)

**9.7. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 7: Adverse Effects: neurological

**9.8. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 8: Adverse effects: psychological

**9.9. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 9: Adverse effects: skin

**9.10. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 10: Adverse effects: urinary

**9.11. Analysis**
Comparison 9: Anticonvulsant vs placebo, Outcome 11: Tolerability/acceptability: loss to follow‐up

**10.1. Analysis**
Comparison 10: Antidepressant vs antidepressant, Outcome 1: Adverse effects: cardiovascular

**10.2. Analysis**
Comparison 10: Antidepressant vs antidepressant, Outcome 2: Adverse effects: gastrointestinal

**11.1. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 1: Irritability (continuous)

**11.2. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 2: Irritability (dichotomous)

**11.3. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 3: Aggression

**11.4. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 4: Adverse effects: gastrointestinal

**11.5. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 5: Adverse events: metabolic

**11.6. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 6: Adverse effects: musculoskeletal pain

**11.7. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 7: Adverse effects: neurological

**11.8. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 8: Adverse events: other

**11.9. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 9: Adverse events: psychological

**11.10. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 10: Adverse events: respiratory

**11.11. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 11: Adverse effects: skin

**11.12. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 12: Serious adverse events

**11.13. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 13: Tolerability/acceptability: loss to follow‐up

**11.14. Analysis**
Comparison 11: Antidementia versus placebo, Outcome 14: Subgroup analysis: age ‐ irritability (continuous)

**12.1. Analysis**
Comparison 12: Antiparkinsonian vs placebo, Outcome 1: Irritability

**12.2. Analysis**
Comparison 12: Antiparkinsonian vs placebo, Outcome 2: Adverse effects: gastrointestinal

**12.3. Analysis**
Comparison 12: Antiparkinsonian vs placebo, Outcome 3: Adverse effects: metabolic

**12.4. Analysis**
Comparison 12: Antiparkinsonian vs placebo, Outcome 4: Adverse effects: neurological

**12.5. Analysis**
Comparison 12: Antiparkinsonian vs placebo, Outcome 5: Adverse effects: psychological

**12.6. Analysis**
Comparison 12: Antiparkinsonian vs placebo, Outcome 6: Tolerability/acceptability: loss to follow‐up

**13.1. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 1: Irritabilty (continuous)

**13.2. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 2: Irritability (dichotomous)

**13.3. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 3: Adverse effects: gastrointestinal

**13.4. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 4: Adverse effects: immune System

**13.5. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 5: Adverse effects: metabolic

**13.6. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 6: Adverse effects: neurological

**13.7. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 7: Adverse effects: psychological

**13.8. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 8: Adverse effects: respiratory system

**13.9. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 9: Adverse effects: skin

**13.10. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 10: Other adverse effects

**13.11. Analysis**
Comparison 13: Anxiolytic versus placebo, Outcome 11: Tolerability/acceptability: loss to follow‐up

**14.1. Analysis**
Comparison 14: Experimental versus placebo, Outcome 1: Irritability

**14.2. Analysis**
Comparison 14: Experimental versus placebo, Outcome 2: Self‐injury

**14.3. Analysis**
Comparison 14: Experimental versus placebo, Outcome 3: Adverse effects: gastrointestinal

**14.4. Analysis**
Comparison 14: Experimental versus placebo, Outcome 4: Adverse effects: immune system

**14.5. Analysis**
Comparison 14: Experimental versus placebo, Outcome 5: Adverse effects: metabolic (dichotomous)

**14.6. Analysis**
Comparison 14: Experimental versus placebo, Outcome 6: Adverse effects: metabolic (continuous)

**14.7. Analysis**
Comparison 14: Experimental versus placebo, Outcome 7: Adverse effects: musculoskeletal

**14.8. Analysis**
Comparison 14: Experimental versus placebo, Outcome 8: Adverse effects: neurological

**14.9. Analysis**
Comparison 14: Experimental versus placebo, Outcome 9: Adverse effects: psychological

**14.10. Analysis**
Comparison 14: Experimental versus placebo, Outcome 10: Adverse effects: respiratory

**14.11. Analysis**
Comparison 14: Experimental versus placebo, Outcome 11: Adverse effects: skin

**14.12. Analysis**
Comparison 14: Experimental versus placebo, Outcome 12: Adverse effects: urinary

**14.13. Analysis**
Comparison 14: Experimental versus placebo, Outcome 13: Adverse effects: other

**14.14. Analysis**
Comparison 14: Experimental versus placebo, Outcome 14: Tolerability/acceptability: loss to follow‐up

**14.15. Analysis**
Comparison 14: Experimental versus placebo, Outcome 15: Subgroup analyses: age ‐ irritability (option 1)

**14.16. Analysis**
Comparison 14: Experimental versus placebo, Outcome 16: Subgroup analyses: age ‐ irritability (option 2)

**14.17. Analysis**
Comparison 14: Experimental versus placebo, Outcome 17: Subgroup analyses: age ‐ self‐injury (option 1)

**14.18. Analysis**
Comparison 14: Experimental versus placebo, Outcome 18: Subgroup analyses: age ‐ self‐injury (option 2)

**15.1. Analysis**
Comparison 15: Typical antipsychotic vs placebo, Outcome 1: Self‐injury

**15.2. Analysis**
Comparison 15: Typical antipsychotic vs placebo, Outcome 2: Adverse effects: musculoskeletal

**15.3. Analysis**
Comparison 15: Typical antipsychotic vs placebo, Outcome 3: Adverse effects: neurological

**15.4. Analysis**
Comparison 15: Typical antipsychotic vs placebo, Outcome 4: Adverse effects: psychological

**15.5. Analysis**
Comparison 15: Typical antipsychotic vs placebo, Outcome 5: Tolerability/acceptabiity: loss to follow‐up

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doi: 10.1002/14651858.CD011769

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Acetylcholinesterase inhibitors for autistic spectrum disorders.
Ure A, Cox GR, Haslam R, Williams K.Ure A, et al.Cochrane Database Syst Rev. 2023 Jun 1;6(6):CD013851. doi: 10.1002/14651858.CD013851.pub2.Cochrane Database Syst Rev. 2023.PMID:37267443Free PMC article.Review.
Access and cost of services for autistic children and adults in Italy: a carers' perspective.
Micai M, Fulceri F, Salvitti T, Romano G, Scattoni ML.Micai M, et al.Front Psychiatry. 2024 Mar 12;15:1299473. doi: 10.3389/fpsyt.2024.1299473. eCollection 2024.Front Psychiatry. 2024.PMID:38532989Free PMC article.
Organisational interventions for preventing and minimising aggression directed towards healthcare workers by patients and patient advocates.
Spelten E, Thomas B, O'Meara PF, Maguire BJ, FitzGerald D, Begg SJ.Spelten E, et al.Cochrane Database Syst Rev. 2020 Apr 29;4(4):CD012662. doi: 10.1002/14651858.CD012662.pub2.Cochrane Database Syst Rev. 2020.PMID:32352565Free PMC article.

References

References to studies included in this review

Akhondzadeh 2004 {published data only}

1. Akhondzadeh S, Erfani S, Mohammadi MR, Tehrani-Doost M, Amini H, Gudarzi SS, et al. Cyproheptadine in the treatment of autistic disorder: a double‐blind placebo‐controlled trial. Journal of Clinical Pharmacy and Therapeutics 2004;29(2):145-50. [DOI: 10.1111/j.1365-2710.2004.00546.x] [PMID: ] - DOI - PubMed

Akhondzadeh 2008 {published data only}

1. Akhondzadeh S, Tajdar H, Mohammadi M-R, Mohammadi M, Nouroozinejad G-H, Shabstari OL, et al. A double-blind placebo controlled trial of piracetam added to risperidone in patients with autistic disorder. Child Psychiatry and Human Development 2008;39(3):237-45. [DOI: 10.1007/s10578-007-0084-3] [PMID: ] - DOI - PubMed

Akhondzadeh 2010 {published data only}

1. Akhondzadeh S, Fallah J, Mohammadi M-R, Imani R, Mohammadi M, Salehi B, et al. Double-blind placebo-controlled trial of pentoxifylline added to risperidone: effects on aberrant behavior in children with autism. Progress in Neuro-Psychopharmacology and Biological Psychiatry 2010;34(1):32-6. [DOI: 10.1016/j.pnpbp.2009.09.012] [PMID: ] - DOI - PubMed

Aman 2017 {published data only}

1. Aman MG, Findling RL, Hardan AY, Hendren RL, Melmed RD, Kehinde-Nelson OK, et al. Safety and efficacy of memantine in children with autism: randomized, placebo-controlled study and open-label extension. Journal of Child and Adolescent Psychopharmacology 2017;27(5):403-12. [DOI: 10.1089/cap.2015.0146] [PMCID: PMC5510039] [PMID: ] - DOI - PMC - PubMed
1. NCT00872898. Study of pharmacokinetics, safety, efficacy, and tolerability of memantine in children with autism [An open-label (part one) and a randomized, double-blind, placebo-controlled (part two) study of the pharmacokinetics, safety, efficacy, and tolerability of memantine in pediatric patients with autism].clinicaltrials.gov/ct2/show/NCT00872898 (first received 31 March 2009).

Anagnostou 2012 {published data only}

1. Anagnosou E, Soorya L, Chaplin W, Bartz J, Halpern D, Wasserman S, et al. Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial. Molecular Autism 2012;3(1):16. [DOI: 10.1186/2040-2392-3-16] [PMCID: PMC3539865] [PMID: ] - DOI - PMC - PubMed
1. NCT00490802. Intranasal oxytocin in the treatment of autism.clinicaltrials.gov/ct2/show/NCT00490802 (first received 25 June 2007).

Aran 2021 {published data only}

1. Aran A, Harel M, Cassuto H, Polyansky K, Schnapp A, Wattad1 N, et al. Cannabinoid treatment for autism: a proof-of-concept randomized trial. Molecular Autism 2021;12(6):6-6. [DOI: 10.1186/s13229-021-00420-2] [PMID: ] - DOI - PMC - PubMed
1. NCT02956226. Cannabinoids for behavioral problems in children with ASD (CBA). (first received 2 November 2016).

Arnold 2006 {published data only}

1. Arnold LE, Aman M, Cook AM, Witwer AN, Hall KL, Thompson S, et al. Atomoxetine for hyperactivity in autism spectrum disorders: placebo-controlled crossover pilot trial. Journal of the American Academy of Child and Adolescent Psychiatry 2006;45(10):1196-205. [DOI: 10.1097/01.chi.0000231976.28719.2a] [PMID: ] - DOI - PubMed

Arnold 2012a {published data only}

1. Arnold LE, Aman MG, Hollway J, Hurt E, Bates B, Li X, et al. Placebo-controlled pilot trial of mecamylamine for treatment of autism spectrum disorders. Journal of Child and Adolescent Psychopharmacology 2012;22(3):198-205. [DOI: 10.1089/cap.2011.0056] [PMCID: PMC3417385] [PMID: ] - DOI - PMC - PubMed
1. NCT00773812. Placebo-controlled pilot trial of mecamylamine for treatment of autism spectrum disorders [Neuronal nicotinic receptor modulation in the treatment of autism: a pilot trial of mecamylamine].clinicaltrials.gov/ct2/show/NCT00773812 (first received 16 October 2008).

Asadabadi 2013 {published data only}IRCT138711091556N2

1. Akhondzadeh S, Asadabadi M. Risperidone plus celecoxib in children with autistic disorder: a double-blind, randomized trial. British Journal of Clinical Pharmacology 2012;73(6):983-4. [DOI: 10.1111/j.1365-2125.2012.04253.x] - DOI
1. Asadabadi M, Mohammadi M-R, Ghanizadeh A, Modabbernia A, Ashrafi M, Hassanzadeh E, et al. Celecoxib as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial. Psychopharmacology 2013;225(1):51-9. [DOI: 10.1007/s00213-012-2796-8] [PMID: ] - DOI - PubMed
1. IRCT138711091556N2. Celecoxib and autism [A double-blind placebo controlled trial of celecoxib added to risperidone in patients with autistic disorder].www.irct.ir/trial/852 (first received 12 February 2009).

Ayatollahi 2020 {published data only}IRCT20090117001556N112

1. Ayatollahi A, Bagheri S, Ashraf-Ganjouei A, Moradi K, Mohammadi M-R, Akhondzadeh S. Does pregnenolone adjunct to risperidone ameliorate irritable behavior in adolescents with autism spectrum disorder: a randomized, double-blind, placebo-controlled clinical trial? Clinical Neuropharmacology 2020;43(5):139-45. [DOI: 10.1097/WNF.0000000000000405] [PMID: ] - DOI - PubMed
1. IRCT20090117001556N112. Efficacy of pregnenolon in treatment of irritability in teenagers with autism [Efficacy of pregnenolon in treatment of irritability in teeanagers with autism; a double blind and placebo controlled triall].www.irct.ir/trial/32775 (first received 25 July 2018).

Batebi 2021 {published data only}IRCT20090117001556N114

1. Batebi N, Moghaddam HS, Hasanzadeh A, Fakour Y, Mohammadi MR, Akhondzadeh S. Folinic acid as adjunctive therapy in treatment of inappropriate speech in children with autism: a double-blind and placebo-controlled randomized trial. Child Psychiatry & Human Development 2021;52(5):928-38. [DOI: 10.1007/s10578-020-01072-8] [PMID: ] - DOI - PubMed
1. IRCT20090117001556N114. Folinic acid in the treatment of autism spectrum disorder [Folinic acid add on therapy to risperidone in symptoms of children with autism: a randomized double-blind placebo-controlled clinical trial].www.irct.ir/trial/35172 (first received 15 November 2018).

Behmanesh 2019 {published data only}IRCT20090117001556N113

1. Behmanesh H, Moghaddam HS, Mohammadi M-R, Akhondzadeh S. Risperidone combination therapy with propentofylline for treatment of irritability in autism spectrum disorders: a randomized, double-blind, placebo-controlled clinical trial. Clinical Neuropharmacology 2019;42(6):189-96. [DOI: 10.1097/WNF.0000000000000368] [PMID: ] - DOI - PubMed
1. IRCT20090117001556N113. Effect of propentofylline in children with autism [Effect of propentofylline add on therapy to risperidon in children with autism: a randomized double-blind placebo-controlled clinical trial].www.irct.ir/trial/35171 (first received 15 November 2018).

Belsito 2001 {published data only (unpublished sought but not used)}

1. Belsito KM, Law PA, Kirk KS, Landa RJ, Zimmerman AW. Lamotrigine therapy for autistic disorder: a randomised, double-blind, placebo-controlled trial. Journal of Autism and Developmental Disorders 2001;31(2):175-81. [DOI: 10.1023/A:1010799115457] [PMID: ] - DOI - PubMed
1. Belsito K, Kirk K, Landa R, Law P, Zimmerman A. Lamotrigine therapy for childhood autism: a randomized, double-blind, placebo-controlled trial. Neurology 1998;50(4):A85. - PubMed

Bernaerts 2020 {published data only}

1. Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up. Molecular Autism 2020;11(1):6. [DOI: 10.1186/s13229-020-0313-1] [PMCID: PMC6964112] [PMID: ] - DOI - PMC - PubMed
1. Bernaerts S, Dillen C, Steyaert J, Alaerts K. The effects of four weeks of intranasal oxytocinon social responsiveness and repetitive and restricted behaviors in autism spectrum disorders: a randomized controlled trial. Biological Psychiatry 2020;81(10):S349-50. [ABSTRACT NO: 864] [DOI: 10.1016/j.biopsych.2017.02.589] - DOI
1. Eudract 2014-000586-45. Oxytocin-based pharmacotherapy for autism spectrum disorders: Investigating the neural and behavioral effects of a promising intervention approach.https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-00058... (first registered May 2014).

Buitelaar 1990 {published data only}

1. Buitelaar JK, Van Engeland H, De Kogel KH, De Vries H, Van Hooff JA, Van Ree JM. The use of adrenocorticotrophic hormone (4-9) analog ORG 2766 in autistic children: effects on the organization of behavior. Biological Psychiatry 1992;31(11):1119-29. [DOI: 10.1016/0006-3223(92)90156-T] [PMID: ] - DOI - PubMed
1. Buitelaar JK, Van Engeland H, Van Ree JM, De Wied D. Behavioral effects of Org 2766, a synthetic analog of the adrenocorticotrophic hormone (4–9), in 14 outpatient autistic children. Journal of Autism and Developmental Disorders 1990;20(4):467-78. [DOI: 10.1007/BF02216053] [PMID: ] - DOI - PubMed

Campbell 1987 {published data only}

1. Campbell M, Adams P, Small AM, Curren EL, Overall JE, Anderson LT, et al. Efficacy and safety of fenfluramine in autistic children. Journal of the American Academy of Child & Adolescent Psychiatry 1988;27(4):434-9. [DOI: 10.1097/00004583-198807000-00010] [PMID: ] - DOI - PubMed

Campbell 1993 {published data only}

1. Campbell M, Anderson LT, Small AM, Adams P, Gonzalez NM, Ernst E. Naltrexone in autistic children: behavioral symptoms and attentional learning. Journal of the American Academy of Child and Adolescent Psychiatry 1993;32(6):1283-91. [DOI: 10.1097/00004583-199311000-00024] [PMID: ] - DOI - PubMed
1. Gonzalez NM, Campbell M, Small AM, Shay J, Bluhm LD, Adams PB, et al. Naltrexone plasma levels, clinical response and effect on weight in autistic children. Psychopharmacology Bulletin 1994;30(2):203-8. [PMID: ] - PubMed

Carey 2002 {published data only}

1. Carey T, Ratcliff-Schaub K, Funk J, Weinle C, Myers M, Jenks J, et al. Double-blind placebo-controlled trial of secretin: effects on aberrant behavior in children with autism. Journal of Autism and Developmental Disorders 2002;32(3):161-7. [DOI: 10.1023/A:1015493412224] [PMID: ] - DOI - PubMed

Chez 2020 {published data only}

1. Chez M, Kile S, Lepage C, Parise C, Benabides B, Hankins A. A randomized, placebo-controlled, blinded, crossover, pilot study of the effects of dextromethorphan/quinidine for the treatment of neurobehavioral symptoms in adults with autism. Journal of Autism and Developmental Disorders 2020;50(5):1532-8. [DOI: 10.1007/s10803-018-3703-x] [PMID: ] - DOI - PubMed

Chugani 2016 {published data only (unpublished sought but not used)}

1. Chugani DC, Chugani HT, Wiznitzer M, Parikh S, Evans PA, Hansen RL, et al. Efficacy of low-dose buspirone for restricted and repetitive behavior in young children with autism spectrum disorder: a randomized trial. Journal of Pediatrics 2016;170:45-53.e1-4. [DOI: 10.1016/j.jpeds.2015.11.033] [PMID: ] - DOI - PubMed
1. NCT00873509. Buspirone in the treatment of 2-6 year old children with autistic disorder (B-ACE) [A randomized, placebo-controlled, double-masked clinical trial of buspirone in the treatment of 2- 6 year old children with autistic disorder]. (first received 1 April 2009).

Dai 2021 {published data only}

1. Dai Y, Zhang L, Yu J, Zhou X, He H, Ji Y, et al. Improved symptoms following bumetanide treatment in children aged 3-6 years with autism spectrum disorder: a randomized, double-blind, placebo-controlled trial. Science Bulletin 2021;66(15):1591-8. [DOI: 10.1016/j.scib.2021.01.008] - DOI - PubMed
1. NCT03156153. A study of bumetanide for the treatment of autism spectrum disorders. (first received 15 May 2017).

Danfors 2005 {published data only}

1. Danfors T, Von Knorring A-L, Hartvig P, Langstrom B, Moulder R, Stromberg B, et al. Tetrahydrobiopterin in the treatment of children with autistic disorder: a double-blind placebo-controlled crossover study. Journal of Clinical Psychopharmacology 2005;25(5):485-9. [DOI: 10.1097/01.jcp.0000177667.35016.e9] [PMID: ] - DOI - PubMed

Danforth 2018 {published data only}

1. Danforth AL, Grob CS, Struble C, Feduccia AA, Walker N, Jerome L, et al. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmaology 2018;235(11):3137-48. [DOI: 10.1007/s00213-018-5010-9] [PMCID: PMC6208958] [PMID: ] - DOI - PMC - PubMed
1. NCT02008396. Phase 2 pilot safety study of MDMA-assisted therapy for socail anxiety in autistic adults. (first received 6 December 2013).

Dean 2019 {published data only}ACTRN12610000635066

1. ACTRN12610000635066. Efficacy Of N-acetyl cysteine in autism: a double-blind, placebo-controlled randomised trial [Efficacy of n-acetyl cysteine on social skills, communication and behaviour in autistic children: a double-blind, placebo-controlled randomised trial].www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=320918 (first received 3 August 2010).
1. Dean OM, Gray K, Dodd S, Villagonzalo K-A, Brown E, Tonge B, et al. Does N-acetylcysteine improve behaviour in children with autism?: a mixed-methods analysis of the effects of N-acetylcysteine. Journal of Intellectual & Developmental Disability 2019;44(4):474-80. [DOI: 10.3109/13668250.2017.1413079] - DOI
1. Dean OM, Gray KM, Villagonzalo K-A, Dodd S, Mohebbi M, Vick T, et al. A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder. Australian and New Zealand Journal of Psychiatry 2017;51(3):241-9. [DOI: 10.1177/0004867416652735] [PMID: ] - DOI - PubMed

DeVane 2019 {published data only}

1. DeVane CL, Charles JM, Abramson RK, Williams JE, Carpenter LA, Raven S, et al. Pharmacotherapy of autism spectrum disorder: results from the randomized BAART clinical trial. Pharmacotherapy 2019;39(6):626-35. [DOI: 10.1002/phar.2271] [PMCID: PMC6555676] [PMID: ] - DOI - PMC - PubMed
1. NCT01333072. Biomarkers in autism of aripiprazole and risperidone treatment (BAART) [Biomarkers in autism of aripiprazole and risperidone treatment].clinicaltrials.gov/ct2/show/NCT01333072 (first received 11 April 2011).

Dollfus 1992 {published data only}

1. Dollfus S, Petit M, Menard JF, Lesieur P. Amisulpride versus bromocriptine in infantile autism: a controlled crossover comparative study of two drugs with opposite effects on dopaminergic function. Journal of Autism and Developmental Disorders 1992;22(1):47-60. [DOI: 10.1007/BF01046402] [PMID: ] - DOI - PubMed
1. Dollfus S, Petit P, Menard JF. Pharmacoclinical study of an agonist and an antagonist of dopamine in early infantile autism. Neuropsychiatrie de l'Enfance et de l'Adolescence 1992;40(5-6):300-309.

Eslamzadeh 2018 {published data only}IRCT2016022826802N1

1. Eslamzadeh M, Hebrani P, Behdani F, Moghadam MD, Panaghi L, Mirzadeh M, et al. Assessment the efficacy of atomoxetine in autism spectrum disorders: a randomized, double-blind, placebo-controlled trial. Iranian Journal of Psychiatry and Behavioral Sciences 2018;12(2):e10596. [DOI: 10.5812/ijpbs.10596] - DOI
1. IRCT2016022826802N1. Assessment the efficacy of atomoxetin(stramox) in autism spectrum disorders 6-17 years old.www.irct.ir/trial/22109 (first received 31 August 2016).

Fankhauser 1992 {published data only}

1. Fankhauser MP, Karamanchi VC, German ML, Yates A, Karamanchi SD. A double-blind, placebo-controlled study of the efficacy of transdermal clonidine in autism. Journal of Clinical Psychiatry 1992;53(3):77-82. [PMID: ] - PubMed

Findling 2014 {published data only}

1. Findling RL, Mankoski R, Timko K, Lears K, McCartney T, McQuade RD, et al. A randomized controlled trial investigating the safety and efficacy of aripiprazole in the long-term maintenance treatment of pediatric patients with irritability associated with autistic disorder. Journal of Clinical Psychiatry 2014;75(1):22-30. [DOI: 10.4088/JCP.13m08500] [PMID: ] - DOI - PubMed
1. NCT01227668. Phase IV long-term maintenance study of aripiprazole in the treatment of irritability associated with autistic disorder.https://clinicaltrials.gov/ct2/show/NCT01227668?term=NCT01227668&draw=2&... (first received October 2010).

Ghaleiha 2013a {published data only}IRCT1138901151556N10

1. Ghaleiha A, Asababadi M, Mohammadi M-R, Shahei M, Tabrizi M, Hajiaghaee R, et al. Memantine as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial. International Journal of Neuropsychopharmacology 2013;16(4):783-9. [DOI: 10.1017/S1461145712000880] [PMID: ] - DOI - PubMed
1. IRCT1138901151556N10. A double-blind placebo-controlled trial of memantine added to risperidone in patients with autistic disorder.https://www.irct.ir/trial/860 (first received May 2010).

Ghaleiha 2013b {published data only}IRCT201107281556N27

1. Ghaleiha A, Mohammadi E, Mohammadi M-R, Farokhnia M, Modabbernia A, Yekehtaz H, et al. Riluzole as an adjunctive therapy to risperidone for the treatment of irritability in children with autistic disorder: a double-blind, placebo-controlled, randomized trial. Pediatric Drugs 2013;15(6):505-14. [DOI: 10.1007/s40272-013-0036-2] [PMID: ] - DOI - PubMed
1. IRCT201107281556N27. Riluzole in the treatment of autism [Riluzole added to risperidone in the treatment of autism: a double blind and placebo controlled trial].en.irct.ir/trial/877 (first received 30 July 2011).

Ghaleiha 2014 {published data only}IRCT201204081556N40

1. Ghaleiha A, Ghyasvand M, Mohammadi M-R, Farokhnia M, Yadegari N, Tabrizi M, et al. Galantamine efficacy and tolerability as an augmentative therapy in autistic children: a randomized, double-blind, placebo-controlled trial. Journal of Psychopharmacology 2014;28(7):677-85. [DOI: 10.1177/0269881113508830] [PMID: ] - DOI - PubMed
1. IRCT201204081556N40. Galantamine in the treatment of autism [Galantamine added to risperidone in the treatment of autism: a double blind and placebo controlled trial].en.irct.ir/trial/890 (first received 14 April 2012).

Ghaleiha 2015 {published data only}IRCT201202281556N37

1. Ghaleiha A, Rasa SM, Nikoo M, Farokhnia M, Mohammadi M-R, Akhondzadeh S. A pilot double-blind placebo-controlled trial of pioglitazone as adjunctive treatment to risperidone: effects on aberrant behavior in children with autism. Psychiatry Research 2015;229(1-2):181-7. [DOI: 10.1016/j.psychres.2015.07.043] [PMID: ] - DOI - PubMed
1. IRCT201202281556N37. Pioglitazone in the treatment of autism [Pioglitazone added to risperidone in the treatment of autism: a double blind and placebo controlled trial].en.irct.ir/trial/887 (first received 1 March 2012).

Ghaleiha 2016 {published data only}IRCT201302201556N50

1. Ghaleiha A, Alikhani R, Kazemi M-R, Mohammadi M-R, Mohammadinejad P, Zeinoddini A, et al. Minocycline as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind placebo-controlled trial. Journal of Child and Adolescent Psychopharmacology 2016;26(9):784-91. [DOI: 10.1089/cap.2015.0175] [PMID: ] - DOI - PubMed
1. IRCT201302201556N50. Minocycline in the treatment of autism [Minocycline added to risperidone in the treatment of autism: a double blind and placebo controlled trial ].en.irct.ir/trial/900 (first received 21 February 2013).

Ghanizadeh 2013 {published data only}IRCT201106103930N6

1. Ghanizadeh A, Moghimi-Sarani E. A randomized double blind placebo controlled clinical trial of N-acetylcysteine added to risperidone for treating autistic disorders. BMC Psychiatry 2013;13:196. [DOI: 10.1186/1471-244X-13-196] [PMCID: PMC3737121] [PMID: ] - DOI - PMC - PubMed
1. IRCT201106103930N6. N-acetylcysteine augmentation with risperidone in treatment of autism in children [N-acetylcysteine augmentation with rispridone in treatment of autism in children: a double blind randomized placebo controlled clinical trial].www.irct.ir/trial/4085 (first received 8 July 2011).

Ghanizadeh 2014 {published data only}IRCT201110233930N15

1. Ghanizadeh A, Sahraeizadeh A, Berk M. A head-to-head comparison of aripiprazole and risperidone for safety and treating autistic disorders, a randomized double blind clinical trial. Child Psychiatry and Human Development 2014;45(2):185-92. [DOI: 10.1007/s10578-013-0390-x] [PMID: ] - DOI - PubMed
1. IRCT201110233930N15. Aripiprazole versus risperidone for treatment of autism.www.irct.ir/trial/4094 (first received 12 December 2011).

Ghanizadeh 2015 {published data only}IRCT201307303930N28

1. Ghanizadeh A, Ayoobzadehshirazi A. A randomized double-blind placebo-controlled clinical trial of adjuvant buspirone for irritability in autism. Pediatric Neurology 2015;52(1):77-81. [DOI: 10.1016/j.pediatrneurol.2014.09.017] [PMID: ] - DOI - PubMed
1. IRCT201307303930N28. A randomized double blind placebo controlled clinical trial of buspirone for treating autism spectrum disorders.www.irct.ir/trial/4107 (first received 4 April 2014).

Gordon 1993 {published data only}

1. Gordon CT, Rapoport JL, Hamburger SD, State RC, Mannheim GB. Differential response of seven subjects with autistic disorder to clomipramine and desipramine. American Journal of Psychiatry 1992;149(3):363-6. [DOI: 10.1176/ajp.149.3.363] - DOI - PubMed
1. Gordon CT, State RC, Nelson JE, Hamburger SD, Rapoport JL. A double-blind comparison of clomipramine, desipramine, and placebo in the treatment of autistic disorder. JAMA 1993;50(6):2441-7. [DOI: 10.1001/archpsyc.1993.01820180039004] - DOI - PubMed

Guastella 2015a {published data only}ACTRN12609000513213

1. ACTRN12609000513213. A course of oxytocin nasal spray (OT) to treat social problems in youth with autism spectrum disorders [A double blind randomised controlled trial of oxytocin nasal spray to treat social problems in autistic youth].www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=83655 (first received 29 June 2009).
1. Guastella AJ, Gray KM, Rinehart NJ, Alvares GA, Tonge BJ, Hickie IB, et al. The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial. Journal of Child Psychology and Psychiatry 2015;56(4):444-52. [DOI: 10.1111/jcpp.12305] [PMID: ] - DOI - PubMed

Hagerman 2018 {published data only}

1. Hagerman R, Potter L, Biag H, Scholze D, Schneider A, Rivera S, et al. A controlled trial of sertraline in children 2 to 6 with ASD without fragile X syndrome. Journal of Intellectual Disability Research 2018;62(8):667-8. [DOI: 10.1111/jir.12512] - DOI
1. NCT02385799. A trial of sertraline in young children with autism spectrum disorder (Sert2).https://clinicaltrials.gov/ct2/show/NCT02385799?term=NCT02385799&draw=2&... (first received March 2015).
1. Potter LA, Scholze DA, Biag HM, Schneider A, Chen Y, Nguyen DV, et al. A randomized controlled trial of sertraline in young children with autism spectrum disorder. Frontiers in Psychiatry 2019;10:810. [DOI: 10.3389/fpsyt.2019.00810] [PMCID: PMC6851992] [PMID: ] - DOI - PMC - PubMed

Hajizadeh‐Zaker 2018 {published data only}IRCT201512081556N83

1. Hajizadeh-Zaker R, Ghajar A, Mesgarpour B, Afarideh M, Mohammadi M-R, Akhondzadeh S. L-carnosine as an adjunctive therapy to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial. Journal of Child and Adolescent Psychopharmacology 2018;28(1):74-81. [DOI: 10.1089/cap.2017.0026] [PMID: ] - DOI - PubMed
1. IRCT201512081556N83. L carnosine in the treatment of autism [L carnosine added to risperidone in the treatment of autism: a double blind and placebo controlled trial].www.irct.ir/trial/932 (first received 9 December 2015).

Handen 2005 {published data only}

1. Handen BL, Hofkosh D. Secretin in children with autistic disorder: a double-blind, placebo-controlled trial. Journal of Developmental and Physical Disabilities 2005;17(2):95-107. [DOI: 10.1007/s10882-005-3682-7] - DOI

Handen 2008 {published data only}

1. Handen BL, Sahl R, Hardan AY. Guanfacine in children with autism and/or intellectual disabilities. Journal of Developmental & Behavioral Pediatrics 2008;29(4):303-8. [DOI: 10.1097/DBP.0b013e3181739b9d] [PMID: ] - DOI - PubMed

Handen 2011 {published data only}

1. Handen BL, Johnson CR, McAuliffe-Bellin S, Hardan A. Safety and efficacy of donepezil in children - behavioural measures. International public health journal 2010;2(1):125-34.
1. Handen BL, Johnson CR, Mcauliffe-Bellin S, Murray PJ, Hardan AY. Safety and efficacy of donepezil in children and adolescents with autism: neuropsychological measures. Journal of Child and Adolescent Psychopharmacology 2011;21(1):43-50. [DOI: 10.1089/cap.2010.0024] [PMCID: PMC3037196] [PMID: ] - DOI - PMC - PubMed
1. Hardan A, Johnson C, Handen BL. Preliminary findings from a double-blind placebo=controlled study of donepezil in pervasive developmental disorders. Biological Psychiatry 2006;59(8):50S-50S.
1. NCT00047697. Donepezil HCl and cognitive deficits in autism.https://clinicaltrials.gov/ct2/show/results/NCT00047697?term=NCT00047697... (first received October 2002).

Handen 2015 {published data only}

1. Arnold LE, Ober N, Aman MG, Handen B, Smith T, Pan X, et al. A 1.5-year follow-up of parent training and atomoxetine for attention-deficit/hyperactivity disorder symptoms and noncompliant/disruptive behavior in autism. Journal of Child and Adolescent Psychopharmacology 2018;28(5):322-30. [DOI: 10.1089/cap.2017.0134] [PMCID: PMC5994674] [PMID: ] - DOI - PMC - PubMed
1. Handen BL, Aman MG, Arnold LE, Hyman SL, Tumuluru RV, Lecavalier L, et al. Atomoxetine, parent training, and their combination in children with autism spectrum disorder and attention-deficit/hyperactivity disorder. Journal of the American Academy of Child & Adolescent Psychiatry 2015;54(11):905-15. [DOI: 10.1016/j.jaac.2015.08.013] [PMCID: PMC4625086] [PMID: ] - DOI - PMC - PubMed
1. Lecavalier L, Pan X, Smith T, Handen BL, Arnold LE, Silverman L, et al. Parent stress in a randomized clinical trial of atomoxetine and parent training for children with autism spectrum disorder. Journal of Autism and Developmental Disorders 2018;48(4):980-7. [DOI: 10.1007/s10803-017-3345-4] [PMCID: PMC6070148] [PMID: ] - DOI - PMC - PubMed
1. NCT00844753. Atomoxetine, placebo and parent management training in autism (Strattera) [Atomoxetine, placebo and parent management training in autism].clinicaltrials.gov/ct2/show/NCT00844753 (first received 16 February 2016).
1. Smith T, Aman MG, Arnold LE, Silverman LB, Lecavalier L, Hollway J, et al. Atomoxetine and parent training for children with autism and attention-deficit/hyperactivity disorder: a 24-week extension study. Journal of the American Academy of Child and Adolescent Psychiatry 2016;55(10):868-76.e2. [DOI: 10.1016/j.jaac.2016.06.015] [PMCID: PMC5108566] [PMID: ] - DOI - PMC - PubMed

Hardan 2012 {published data only}

1. Hardan A. Psychopharmacological treatment of anxiety symptoms in autism spectrum disorder. Journal of the American Academy of Child and Adolescent Psychiatry 2016;55(10):S325-6. [DOI: 10.1016/j.jaac.2016.07.369] [ABSTRACT NO: 42.4] - DOI
1. Hardan AY, Fung LK, Libove RA, Obukhanych TV, Nair S, Herzenberg LA, et al. A randomised controlled pilot trial of N-acetylcysteine in children with autism. Biological Psychiatry 2012;71(11):956-61. [DOI: 10.1016//j.biopsych.2012.01.014] [PMCID: PMC4914359] [PMID: ] - DOI - PMC - PubMed

Hardan 2019 {published data only}

1. EUCTR 2012-001568-31. A double-blind, placebo-controlled, randomized withdrawal study of the safety and efficacy of memantine in pediatric patients with autism, Asperger’s disorder, or pervasive developmental disorder not otherwise specified (PDD-NOS) previously treated with memantine.www.clinicaltrialsregister.eu/ctr-search/trial/2012-001568-31/results (first posted November 2012).
1. Hardan AY, Hendren RL, Aman MG, Robb A, Melmed RD, Andersen KA, et al. Efficacy and safety of memantine in children with autism spectrum disorder: results from three phase 2 multicenter studies. Autism 2019;23(8):2096-111. [DOI: 10.1177/1362361318824103] [PMCID: PMC6779018] [PMID: ] - DOI - PMC - PubMed
1. NCT01592747. Withdrawal study of memantine in pediatric patients with autism, Asperger's disorder, or pervasive developmental disorder not otherwise specified previously treated with memantine [A double-blind, placebo-controlled, randomized withdrawal study of the safety and efficacy of memantine in pediatric patients with autism, Asperger's disorder, or pervasive developmental disorder not otherwise specified (pdd-nos) previously treated with memantine].clinicaltrials.gov/ct2/show/results/NCT01592747 (first received 7 May 2012).

Harfterkamp 2014 {published data only}

1. Harfterkamp M, Buitelaar JK, Minderaa RB, Van de Loo-Neus G, Van De Gaag R-J, Hoekstra PJ. Atomoxetine in autism spectrum disorder: no effects on social functioning; some beneficial effects on stereotyped behaviours; inappropriate speech and fear of change. Journal of Child and Adolescent Psychopharmacology 2014;24(9):481-5. [DOI: 10.1089/cap.2014.0026] [PMID: ] - DOI - PubMed
1. Harfterkamp M, Van Der Meer J. Randomized double-blind study of atomoxetine vs. placebo followed by an open label extension period of treatment with atomoxetine for ADHD symptoms in children with ASD. European Child and Adolescent Psychiatry 2013;22(2):S216-17. [DOI: 10.1007/s00787-013-0423-9] [ABSTRACT NO: PS-012] - DOI
1. Harfterkamp M, Van de Loo-Neus G, Minderaa RB, Van der Gaag R-J, Escobar R, Schacht A, et al. A randomized double-blind study of atomoxetine versus placebo for attention-deficit/hyperactivity disorder symptoms in children with autism spectrum disorder. Journal of the American Academy of Child and Adolescent Psychiatry 2012;51(7):733-41. [DOI: 10.1016/j.jaac.2012.04.011] [PMID: ] - DOI - PubMed
1. NCT00380692. Atomoxetine versus placebo for symptoms of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents with autism spectrum disorder [A randomized, double-blind comparison of atomoxetine hydrochloride and placebo for symptoms of attention-deficit/hyperactivity disorder in children and adolescents with autism spectrum disorder].clinicaltrials.gov/ct2/show/NCT00380692 (first received 26 September 2006).

Hellings 2005 {published data only}

1. Hellings JA, Weckbaugh M, Nickel EJ, Cain SE, Zarcone JR, Reese RM, et al. A double-blind, placebo-controlled study of valproate for aggression in youth with pervasive developmental disorders. Journal of Child and Adolescent Psychopharmacology 2005;15(4):682-92. [DOI: 10.1089/cap.2005.15.682] [PMID: ] - DOI - PubMed

Hendouei 2019 {published data only}IRCT20090117001556N104

1. Hendouei F, Moghaddam HS, Mohammadi MR, Taslimi N, Rezaei F, Akhondzadeh S. Resveratrol as adjunctive therapy in treatment of irritability in children with autism: a double‐blind and placebo‐controlled randomized trial. Journal of Clinical Pharmacy and Therapeutics 2020;45(2):324-34. [DOI: 10.1111/jcpt.13076] [PMID: ] - DOI - PubMed
1. IRCT20090117001556N104. Resveratrol in treatment of autism [Resveratrol add on therapy to risperidone in irritibility of children with autism: a randomized double-blind placebo-controlled clinical trial].www.irct.ir/trial/28378 (first received 25 December 2012).

Herscu 2020 {published data only}

1. Herscu P, Handen BL, Arnold LE, Snape MF, Bregman JD, Ginsberg L, et al. The SOFIA Study: negative multi‑center study of low dose fluoxetine on repetitive behaviors in children and adolescents with autistic disorder. Journal of Autism and Developmental Disorders 2020;50(9):3233-44. [DOI: 10.1007/s10803-019-04120-y] [PMID: ] - DOI - PubMed
1. NCT00515320. Study of fluoxetine in autism (SOFIA) [Study of fluoxetine in autism: a randomised, double-blind, placebo-controlled, parallel-group 14-week study to investigate the effect of fluoxetine orally dissolving tablet (odt) on repetitive behaviors in childhood and adolescent autistic disorder].clinicaltrials.gov/ct2/show/NCT00515320 (first received 13 August 2007).

Hollander 2005 {published data only}

1. Hollander E, Swanson E, Anagnostou E, Phillips A, Chaplin W, Wasserman S. Liquid fluoxetine versus placebo for repetitive behaviors in childhood autism. Progress in Neurotherapeutics and Neuropsychopharmacology 2006;1(1):105-13. [DOI: 10.1017/S1748232105000108] - DOI
1. HollanderE, Phillips A, Chaplin W, Zagursky K, Novotny S, Wasserman S, et al. A placebo controlled crossover trial of liquid fluoxetine on repetitive behaviours in childhood and adolescent autism. Neuropsychopharmacology 2005;30(3):582-9. [DOI: 10.1038/sj.npp.1300627] [PMID: ] - DOI - PubMed
1. NCT00004486. Randomized study of fluoxetine in children and adolescents with autism.clinicaltrials.gov/ct2/show/NCT00004486 (first received 19 October 1999).

Hollander 2006a {published data only}

1. Hollander E, Soorya L, Wasserman S, Esposito K, Chaplin W, Anagnostou E. Divalproex sodium vs placebo in the treatment of repetitive behaviours in autism spectrum disorder. International Journal of Neuropsychopharmacology 2006;9(2):209-13. [DOI: 10.1017/S1461145705005791] [PMID: ] - DOI - PubMed
1. NCT00211757. Divalproex sodium versus placebo in childhood/adolescent autism.https://clinicaltrials.gov/ct2/show/results/NCT00211757?term=NCT00211757... (first received September 2005).

Hollander 2006b {published data only}

1. Hollander E, Wasserman S, Swanson EN, Chaplin W, Schapiro ML, Zagursky K, et al. A double-blind placebo-controlled pilot study of olanzapine in childhood/adolescent pervasive developmental disorder. Journal of Child and Adolescent Psychopharmacology 2006;16(5):541-8. [DOI: 10.1089/cap.2006.16.541] [PMID: ] - DOI - PubMed

Hollander 2010 {published data only}

1. Anagnostou E, Soorya L, Swanson E, Rusoff J, Chaplin W, Wasserman S, et al. Divalproex sodium vs placebo for the treatment of child and adolescent autism. European Neuropsychopharmacology 2006;16:S74-5. [DOI: 10.1016/S0924-977X(06)80088-X] - DOI
1. Hollander E, Chaplin W, Soorya L, Wasserman S, Novotny S, Rusoff J, et al. Divalproex sodium vs placebo for the treatment of irritability in children and adolescents with autism spectrum disorders. Neuropsychopharmacology 2010;35(4):990-8. [DOI: 10.1038/npp.2009.202] [PMCID: PMC2846602] [PMID: ] - DOI - PMC - PubMed
1. Hollander E, Soorya L, Wasserman S, Esposito K, Chaplin W, Anagnostou E. Divalproex sodium vs placebo in the treatment of repetitive behaviours in autism spectrum disorder. International Journal of Neuropsychopharmacology 2006;9(2):209-13. [DOI: 10.1017/S1461145705005791] [PMID: ] - DOI - PubMed
1. NCT00211757. Divalproex sodium vs. placebo in childhood/adolescent autism.https://clinicaltrials.gov/ct2/show/NCT00211757?term=NCT00211757&draw=1&... (first received September 2005).

Hollander 2012 {published data only (unpublished sought but not used)}

1. Hollander E, Soorya L, Chaplin W, Anagnostou E, Taylor BP, Ferretti CJ, et al. A double-blind placebo-controlled trial of fluoxetine for repetitive behaviors and global severity in adult autism spectrum disorders. American Journal of Psychiatry 2012;169(3):292-9. Erratum in: American Journal of Psychiatry. 2012 May;169(5):540. [DOI: 10.1176/appi.ajp.2011.10050764] [PMID: ] - DOI - PubMed
1. NCT00004486. Randomized study of fluoxetine in children and adolescents with autism.https://clinicaltrials.gov/show/NCT00004486 (first received 19 October 1999).

Hollander 2020a {published data only}

1. Hollander E, Ferretti CJ, Taylor BP, Noone RH, Racine E. P.7.d.006 Trichuris suis ova (TSO) as an immune-inflammatory treatment for repetitive behaviors in autism spectrum disorders (ASD). European Neuropsychopharmacology 2014;24(2):S723. [DOI: 10.1016/S0924-977X(14)71165-4] - DOI
1. Hollander E, Uzunova G, Taylor BP, Noone R, Racine E, Doernberg E, et al. Randomized crossover feasibility trial of helminthic Trichuris suis ova versus placebo for repetitive behaviors in adult autism spectrum disorder. World Journal of Biological Psychiatry 2020;21(4):291-9. [DOI: 10.1080/15622975.2018.1523561] [PMID: ] - DOI - PubMed
1. Hollander E, Ferretti C, Taylor B, Noone R, Kirsch J, Racine E. Trichuris suis ova (TSO) as an immune inflammatory treatment for repetitive behaviors in ASD. Neuropsychopharmacology 2013;38:S391-2. [DOI: 10.1038/npp.2013.280] - DOI
1. Hollander E, Uzunova G, Taylor BP, Noone R, Racine E, Doernberg E, et al. Randomized crossover feasibility trial of helminthic Trichuris suis ova versus placebo for repetitive behaviors in adult autism spectrum disorder. World Journal of Biological Psychiatry 2020;21(4):291-9. [DOI: 10.1080/15622975.2018.1523561] [PMID: ] - DOI - PubMed
1. NCT01040221. Trichuris suis ova in autism spectrum disorders (TSO) [Trichuris suis ova in autism spectrum disorders ].www.clinicaltrials.gov/ct2/show/NCT01040221 (first received November 2012).

Hollander 2020b {published data only}

1. Hollander E, Jacob S, Jou R, McNamara N, Sikich L, Tobe R, et al. A phase 2 randomized controlled trial (RCT) of balovaptan (BAL) in pediatric participants with autism spectrum disorder (ASD). Neuropsychopharmacology 2021;46:152. [DOI: 10.1038/s41386-021-01236-7] - DOI
1. Hollander E, Jacob S, Jou RJ, McNamara N, Sikich L, Tobe R, et al. Phase 2 randomized controlled trial of balovaptan in pediatric participants with autism spectrum disorder. Journal of the American Academy of Child and Adolescent Psychiatry 2020;59(10):S262-S263. [DOI: 10.1016/j.jaac.2020.08.458] - DOI
1. NCT02901431. A study to investigate the efficacy and safety of balovaptan (RO5285119) in participants with autism spectrum disorder (ASD).www.clinicaltrials.gov/ct2/show/NCT02901431?term=NCT02901431&draw=2&rank=1 (first received 21 November 2016).

Ichikawa 2017 {published data only}

1. Ichikawa H, Mikami K, Okada T, Yamashita Y, Ishizaki Y, Tomoda A, et al. Aripiprazole in the treatment of irritability in children and adolescents with autism spectrum disorder in Japan: a randomized, double-blind, placebo-controlled study. Child Psychiatry & Human Development 2017;48(5):796-806. [DOI: 10.1007/s10578-016-0704-x] [PMCID: PMC5617873] [PMID: ] - DOI - PMC - PubMed
1. NCT01617447. A short treatment study of aripiprazole in pediatric patients with autistic disorder [A short-term administration study of aripiprazole in children and adolescents (age: 6 to 17 years) with autistic disorder].clinicaltrials.gov/ct2/show/NCT01617447 (first received 12 June 2012).

Jacob 2022 {published data only}

1. Jacob S, Veenstra-VanderWeele J, Murphy D, McCracken J, Smith J, Sanders K, et al. Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial. Lancet 2022;9(3):199-210. [DOI: 10.1016/S2215-0366(21)00429-6] [PMID: ] - DOI - PubMed
1. Jacob S, Veenstra-VanderWeele J, Murphy D, McCracken J, Smith J, Sanders K, et al. Phase three randomised controlled trial of balovaptan in adults with autism spectrum disorder. Journal of the American Academy of Child and Adolescent Psychiatry 2020;59(10):S163-S163. [DOI: 10.1016/j.jaac.2020.08.108] - DOI
1. NCT03504917. A study of balovaptan in adults with autism spectrum disorder with a 2-year open-label extension.clinicaltrials.gov/ct2/show/NCT03504917?term=NCT03504917&draw=2&rank=1 (first received 8 August 2018).

Jaselskis 1992 {published data only}

1. Jaselskis CA, Cook EH, Fletcher KE, Leventhal BL. Clonidine treatment of hyperactive and impulsive children with autistic disorder. Journal of Clinical Psychopharmacology 1992;12(5):322-7. [PMID: ] - PubMed

Kent 2013 {published data only}

1. Kent JM, Kushner S, Ning X, Karcher K, Ness S, Aman M, et al. Risperidone dosing in children and adolescents with autistic disorder: a double-blind placebo-controlled study. Journal of Autism and Developmental Disorders 2013;43(8):1773-83. [DOI: 10.1007/s10803-012-1723-5] [PMID: ] - DOI - PubMed
1. NCT00576732. A study of the effectiveness and safety of two doses of risperidone in the treatment of children and adolescents with autistic disorder [Risperidone in the treatment of children and adolescents with autistic disorder: a double-blind, placebo-controlled study of efficacy and safety, followed by an open-label extension study of safety].clinicaltrials.gov/ct2/show/NCT00576732 (first received 19 December 2007).

Khalaj 2018 {published data only}IRCT201702171556N96

1. IRCT201702171556N96. Palmitoylethanolamide as adjunctive treatment of autism: a double blind and placebo controlled trial.en.irct.ir/trial/945 (first received 20 February 2017).
1. Khalaj M, Saghazadeh A, Shirazi E, Shalbafan M-R, Alavi K, Shooshtari MH, et al. Palmitoylethanolamide as adjunctive therapy for autism: efficacy and safety results from a randomized controlled trial. Journal of Psychiatric Research 2018;103:104-11. [DOI: 10.1016/j.jpsychires.2018.04.022] [PMID: ] - DOI - PubMed

King 2001 {published data only (unpublished sought but not used)}

1. King BH, Wright DM, Handen BL, Sikich L, Zimmerman AW, Mcmahon W, et al. Double-blind, placebo-controlled study of amantadine hydrochloride in the treatment of children with autistic disorder. Journal of the American Academy of Child & Adolescent Psychiatry 2001;40(6):658-65. [DOI: 10.1097/00004583-200106000-00010] [PMID: ] - DOI - PubMed

King 2009 {published data only}

1. King BH, Hollander E, Sikich L, McCracken JT, Scahill L, Bregman JD, et al. Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism. Archives of General Psychiatry 2009;66(6):583-90. [DOI: 10.1001/archgenpsychiatry.2009.30] [PMCID: PMC4112556] [PMID: ] - DOI - PMC - PubMed
1. Myers SM. Citalopram not effective for repetitive behavior in autistic spectum disorders. Evidence-Based Mental Health 2010;13(1):22. [DOI: 10.1136/ebmh.13.1.22] [PMID: ] - DOI - PubMed
1. NCT00086645. Citalopram for children with autism and repetitive behavior (STAART Study 1) [Citalopram treatment in children with autism spectrum disorders and high levels of repetitive behavior].clinicaltrials.gov/ct2/show/NCT00086645 (first received 13 July 2004).
1. Scahill L, McCracken JT, Bearss K, Robinson F, Hollander E, King B, et al. Design and subject characteristics in the federally-funded citalopram trial in children with pervasive developmental disorders. Journal of Autism and Developmental Disorders 2012;42(3):432-40. [DOI: 10.1007/s10803-011-1251-8] [PMID: ] - DOI - PubMed

Klaiman 2013 {published data only}

1. Klaiman C, Huffman L, Masaki L, Elliott GR. Tetrahydrobiopterin as a treatment for autism spectrum disorders: a double-blind, placebo-controlled trial. Journal of Child and Adolescent Psychopharmacology 2013;13(5):320-8. [DOI: 10.1089/cap.2012.0127] [PMID: ] - DOI - PubMed
1. NCT00850070. Sapropterin as a treatment for autistic disorder.https://clinicaltrials.gov/ct2/show/results/NCT00850070?term=NCT00850070... (first received February 2009).

Le 2022 {published data only}ChiCTR1900023774

1. ChiCTR1900023774. The effects of chronic intranasal oxytocin combined with positive social interaction in the treatment of young children with autism.www.chictr.org.cn/showproj.aspx?proj=39640 (first received 11 June 2019).
1. Le J, Zhang L, Zhao W, Zhi S, Lan C, Kou J, et al. Infrequent intranasal oxytocin followed by positive social interaction improves symptoms in autistic children: a pilot randomized clinical trial. Psychotherapy and Psychosomatics 2022;91(5):335-47. [DOI: 10.1159/000524543] [PMID: ] - DOI - PubMed

Lemonnier 2017 {published data only}

1. Lemonnier E, Villeneuve N, Sonie S, Rosier A, Roue M, Brosset P, et al. Effects of bumetanide on neurobehavioral function in children and adolescents with autism spectrum disorders. Translational Psychiatry 2017;7(3):e1056. [DOI: 10.1038/tp.2017.10] [PMCID: PMC5416661] [PMID: ] - DOI - PMC - PubMed
1. NCT01078714. Efficiency of bumetanide in autistic children (BUMEA).https://clinicaltrials.gov/ct2/show/NCT01078714?term=NCT01078714&draw=1&... (first received March 2010).

Levy 2003 {published data only}

1. Levy SE, Souders MC, Wray J, Jawad AF, Gallagher PR Coplin J, et al. Children with autistic spectrum disorders. I: comparison of placebo and single dose of human synthetic secretin. Archives of Disease in Childhood 2003;88(8):731-6. [DOI: 10.1136/adc.88.8.731] [PMCID: PMC1719589] [PMID: ] - DOI - PMC - PubMed

Lewis 2018 {published data only}

1. Lewis AS, Van Schalkwy GI, Lopez MO, Volkmar FR, Picciotto MR, Sukhodolsky DG. An exploratory trial of transdermal nicotine for aggression and irritability in adults with autism spectrum disorder. Journal of Autism and Developmental Disorders 2018;48(8):2748-57. [DOI: 10.1007/s10803-018-3536-7] [PMCID: PMC6394231] [PMID: ] - DOI - PMC - PubMed
1. NCT02552147. Nicotinic cholinergic modulation as a novel treatment strategy for aggression associated with autism [Nicotinic cholinergic modulation as a novel treatment strategy for aggression associated with autism].clinicaltrials.gov/ct2/show/NCT02552147 (first received 16 September 2015).

Loebel 2016 {published data only}

1. Loebel A, Brams M, Goldman RS, Silva R, Hernandez D, Deng L, et al. Lurasidone for the treatment of irritability associated with autistic disorder. Journal of Autism and Developmental Disorders 2016;46(4):1153-63. [DOI: 10.1007/s10803-015-2628-x] [PMCID: PMC4786592] [PMID: ] - DOI - PMC - PubMed
1. NCT01911442. Lurasidone pediatric autism study.https://clinicaltrials.gov/ct2/show/results/NCT01911442?term=NCT01911442... (first received July 2013).

Luby 2006 {published data only}

1. Luby J, Mrakotsky C, Stalets MM, Belden A, Heffelfinger A, Williams M, et al. Risperidone in preschool children with autistic spectrum disorders: an investigation of safety and efficacy. Journal of Child and Adolescent Psychopharmacology 2006;16(5):575-87. [DOI: 10.1089/cap.2006.16.575] [PMID: ] - DOI - PubMed

Mace 2001 {published data only (unpublished sought but not used)}

1. Mace CF, Blum NJ, Sierp BJ, Delaney BA, Mauk JE. Differential response of operant self-Injury to pharmacologic versus behavioral treatment. Journal of Developmental & Behavioral Pediatrics 2001;22(2):85-91. [DOI: 10.1097/00004703-200104000-00001] [PMID: ] - DOI - PubMed

Mahdavinasab 2019 {published data only}IRCT201701131556N95

1. IRCT201701131556N95. Baclofen in the treatment of autism [Baclofen as adjunctive treatment of autism: a double blind and placebo controlled trial].www.irct.ir/trial/944 (first received 13 January 2017).
1. Mahdavinasab S-M, Saghazadeh A, Motamed-Gorji N, Vaseghi S, Mohammadi M-R, Alichani R, et al. Baclofen as an adjuvant therapy for autism: a randomized, double-blind, placebo-controlled trial. European Child & Adolescent Psychiatry 2019;28(12):1619-28. [DOI: 10.1007/s00787-019-01333-5] [PMID: ] - DOI - PubMed

Malek 2020 {published data only}IRCT20090117001556N102

1. IRCT20090117001556N102. Prednisolone in autism spectrum disorders [Prednisolone in regressive autism spectrum disorders: a randomized double-blind placebo-controlled clinical trial].www.irct.ir/trial/28026 (first received 9 December 2017).
1. Malek M, Ashraf-Ganjouei A, Moradi K, Bagheri S, Mohammadi M-R, Akhonzadeh S. Prednisolone as adjunctive treatment to risperidone in children with regressive type of autism spectrum disorder: a randomized, placebo-controlled trial. Clinical Neuropharmacology 2020;43(2):39-45. [DOI: 10.1097/WNF.0000000000000382] [PMID: ] - DOI - PubMed

Malone 2001 {published data only}

1. Malone RP, Cater J, Sheikh RM, Choudhury MS, Delaney MA. Olanzapine versus haloperidol in children with autistic disorder: an open pilot study. Journal of the American Academy of Child and Adolescent Psychiatry 2001;40(8):887-94. [DOI: 10.1097/00004583-200108000-00009] [PMID: ] - DOI - PubMed

Marcus 2009 {published data only}

1. Benton TD. Aripiprazole to treat irritability associated with autism: a placebo-controlled, fixed-dose trial. Current Psychiatric Reports 2011;13(2):77-9. [DOI: 10.1007/s11920-010-0172-0] [PMID: ] - DOI - PubMed
1. Curran MP. Aripiprazole in the treatment of irritability associated with autistic disorder in paediatric patients: profile report. CNS Drugs 2011;25(9):801-2. [DOI: 10.2165/11208280-000000000-00000] [PMID: ] - DOI - PubMed
1. Lewis D, Couch D, Marcus R, Manos G, Mankoski R, Carson W, et al. Efficacy and safety of fixed-dose aripiprazole for the treatment of irritability associated with autistic disorder in children and adolescents (6-17 years). Annals of Neurology 2009;66:S110.
1. Mankosky R, Stockton G, Manos G, Marler S, McQuade R, Forbes RA, et al. Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. Journal of Child and Adolescent Psychopharmacology 2013;23(8):572-6. [DOI: 10.1089/cap.2012.0075] [PMCID: PMC3804231] [PMID: ] - DOI - PMC - PubMed
1. Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, et al. A placebo-controlled, fixed-dose aripiprazole in children and adolescents with irritability associated with autistic disorder. Journal of the American Academy of Child and Adolescent Psychiatry 2009;48(11):1110-9. [DOI: 10.1097/CHI.0b013e3181b76658] [PMID: ] - DOI - PubMed

McCracken 2002 {published data only}

1. Aman M, Rettiganti M, Nagaraja HN, Hollway JA, McCracken J, McDougle CJ, et al. Tolerability, safety, and benefits of risperidone in children and adolescents with autism: 21-month follow-up after 8-week placebo-controlled trial. Journal of Child & Adolescent Psychopharmacology 2015;25(6):482-93. [DOI: 10.1089/cap.2015.0005] [PMCID: PMC4545698] [PMID: ] - DOI - PMC - PubMed
1. Aman MG, Arnold LE, McDougle CJ, Vitiello B, Scahill L, Davies MD, et al. Acute and long-term safety and tolerability of risperidone in children with autism. Journal of Child and Adolescent Psychopharmacology 2005;15(6):869-84. [DOI: 10.1089/cap.2005.15.869] [PMID: ] - DOI - PubMed
1. Aman MG, Hollway JA, McDougle CJ, Scahill L, Tierney E, McCracken JT, et al. Cognitive effects of risperidone in children with autism and irritable behavior. Journal of Child and Adolescent Psychopharmacology 2008;18(3):227-36. [DOI: 10.1089/cap.2007.0133] [PMCID: PMC2935828] [PMID: ] - DOI - PMC - PubMed
1. Arnold LE, Aman MG, Martin A, Collier-Crespin A, Vitiello B, Tierney E, et al. Assessment in multisite randomized clinical trials of patients with autistic disorder: the Autism RUPP Network. Research Units on Pediatric Psychopharmacology. Journal of Autism and Developmental Disorders 2000;30(2):99-111. [DOI: 10.1023/a:1005451304303] [PMID: ] - DOI - PubMed
1. Arnold LE, Farmer C, Kraemer HC, Davies M, Witwer A, Chuang S, et al. Moderators, mediators, and other predictors of risperidone response in children with autistic disorder and irritability. Journal of Child & Adolescent Psychopharmacology 2010;20(2):83-93. [DOI: 10.1089/cap.2009.0022] [PMCID: PMC2865212] [PMID: ] - DOI - PMC - PubMed

McDougle 1996 {published data only (unpublished sought but not used)}

1. Huffman G. Fluvoxamine for the treatment of autistic disorders in adults. American Family Physician 1997;55(4):1375-4.
1. McDougle CJ, Naylor ST, Cohen DJ, Volkmar FR, Heninger GR, Price LH. A double-blind, placebo-controlled study of fluvoxamine in adults with autistic disorder. Archives of General Psychiatry 1996;53(11):1001-8. [DOI: 10.1001/archpsyc.1996.01830110037005] [PMID: ] - DOI - PubMed
1. Vegso SJ. A double-blind placebo-controlled study of fluvoxamine in treating the symptoms of autism [Master's thesis]. New Haven (CT): Southern Connecticut State University, 1995.

McDougle 1998 {published data only}

1. McDougle CJ, Holmes JP, Carlson DC, Pelton GH, Cohen DJ, Price LH. A double-blind, placebo-controlled study of risperidone in adults with autistic disorder and other pervasive developmental disorders. Archives of General Psychiatry 1998;55(7):633-41. [DOI: 10.1001/archpsyc.55.7.633] [PMID: ] - DOI - PubMed

Minshawi 2016 {published data only}

1. Minshawi NF, Wink LK, Shaffer R, Plawecki MH, Posey DJ, Liu H, et al. A randomized, placebo-controlled trial of D-cycloserine for the enhancement of social skills training in autism spectrum disorders. Molecular Autism 2016;7(3):2. [DOI: 10.1186/s13229-015-0062-8] [PMCID: PMC4712595] [PMID: ] - DOI - PMC - PubMed
1. NCT01086475. D-cycloserine and social skills training in autism spectrum disorders.https://clinicaltrials.gov/ct2/show/NCT01086475?term=NCT01086475&draw=1&... (first received March 2010).
1. Wink LK, Minshawi NF, Shaffer RC, Plawecki MH, Posey DJ, Horn PS, et al. D-cycloserine enhances durability of social skills training in autism spectrum disorder. Molecular Autism 2017;8:2. [DOI: 10.1186/s13229-017-0116-1] [PMCID: PMC5264460] [PMID: ] - DOI - PMC - PubMed

Miral 2008 {published data only (unpublished sought but not used)}

1. Miral S, Gencer O, Inal-Emiroglu FN, Baykara B, Baykara A, Dirik E. Risperidone versus haloperidol in children and adolescents with AD: a randomized, controlled, double-blind trial. European Child & Adolescent Psychiatry 2008;17(1):1-8. [DOI: 10.1007/s00787-007-0620-5] [PMID: ] - DOI - PubMed

Moazen‐Zadeh 2018 {published data only}

1. IRCT201602041556N86. Simvastatin added to risperidone in the treatment of autism: a double blind and placebo controlled trial.https://www.irct.ir/trial/935 (first received February 2016).
1. Moazen-Zadeh E, Shirzad F, Karkhaneh-Yousefi M-A, Khezri R, Mohammadi M-R, Akhondzadeh S. Simvastatin as an adjunctive therapy to risperidone in treatment of autism: a randomized, double-blind, placebo-controlled clinical trial. Journal of Child and Adolescent Psychopharmacology 2018;28(1):82-9. [DOI: 10.1089/cap.2017.0055] [PMID: ] - DOI - PubMed

Mohammadi 2013 {published data only}IRCT201106101556N25

1. IRCT201106101556N25. Amantadine in the treatment of autism [A double - blind placebo controlled traial of amantadine added to risperidone in patint with autistic disorder].www.irct.ir/trial/875 (first received 12 June 2011).
1. Mohammadi M-R, Yadegari N, Hassanzadeh E, Farokh M, Yekehtaz H, Mirshafiee O, et al. Double-blind, placebo-controlled trial of risperidone plus amantadine in children with autism: a 10-week randomized study. Clinical Neuropharmacology 2013;36(6):179-84. [DOI: 10.1097/WNF.0b013e3182a9339d] [PMID: ] - DOI - PubMed

Montazmenesh 2020 {published data only}IRCT20090117001556N107

1. IRCT20090117001556N107. Sulforaphane as adjunctive treatment of irritability in children with autism spectrum disorder [Sulforaphane treatment of autism spectrum disorder: a double blind controlled trial].www.irct.ir/trial/30363 (first received 6 April 2018).
1. Montazmenesh S, Amirimoghaddam-Yazdi Z, Moghaddam HS, Mohammadi MR, Akhondzadeh S. Sulforaphane as an adjunctive treatment for irritability in children with autism spectrum disorder: a randomized, double-blind, placebo-controlled clinical trial. Psychiatry and Clinical Neurosciences 2020;74(7):398-405. [DOI: 10.1111/pcn.13016] [PMID: ] - DOI - PubMed

Mouti 2014 {published and unpublished data}

1. Mouti A, Reddihough D, Marraffa C, Hazell P, Wray J, Lee KL, et al. Fluoxetine for autistic behaviors (FAB trial): study protocol for a randomized controlled trial in children and adolescents with autism. Trials 2014;15:230. [DOI: 10.1186/1745-6215-15-230] [PMCID: PMC4067505] [PMID: ] - DOI - PMC - PubMed
1. Reddihough DS, Marraffa C, Mouti A, O'Sullivan M, Lee KJ, Orsini F, et al. Effect of fluoxetine on obsessive-compulsive behaviours in children and adolescents with autism spectrum disorders: a randomized clinical trial. JAMA 2019;322(16):1561-9. [DOI: 10.1001/jama.2019.14685] [PMCID: PMC6806436] [PMID: ] - DOI - PMC - PubMed

Munesue 2016 {published data only (unpublished sought but not used)}UMIN000007250

1. Munesue T, Nakamura H, Kikuchi M, Miura Y, Takeuchi N, Anme T, et al. Oxytocin for male subjects with autism spectrum disorder and comorbid intellectual disabilities: a randomized pilot study. Frontiers in Psychiatry 2016;7:2. [DOI: 10.3389/fpsyt.2016.00002] [PMCID: PMC4720778] [PMID: ] - DOI - PMC - PubMed
1. UMIN000007250. A randomized, double-blind, placebo-controlled, cross-over trial of oxytocin in patients with autism spectrum disorder.center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008548 (first received 9 February 2012).

NCT00183339 {published data only}

1. NCT00183339. Early intervention with fluoxetine in autism [A randomized, placebo-controlled trial of fluoxetine in preschool children].clinicaltrials.gov/ct2/show/NCT00183339 (first received 16 September 2005).

NCT00198107 {published data only}

1. NCT00198107. Evaluating the effectiveness of aripiprazole and D-cycloserine to treat symptoms associated with autism [Novel pharmacological strategies in autism].clinicaltrials.gov/ct2/show/NCT00198107 (first received 20 September 2005).

NCT00468130 {published data only}

1. NCT00468130. Efficacy of aripiprazole versus placebo in the reduction of aggressive and aberrant behavior in autistic children (Abilify) [Efficacy of aripiprazole versus placebo in the reduction of aggressive and aberrant behavior in autistic children].clinicaltrials.gov/ct2/show/NCT00468130 (first received 2 May 2007).

NCT00498173 {published data only}

1. NCT00498173. Effectiveness of atomoxetine in treating ADHD symptoms in children and adolescents with autism [Targeted pharmacologic interventions for autism: a double-blind, placebo-controlled trial of atomoxetine in children and adolescents with autism].clinicaltrials.gov/ct2/show/NCT00498173 (first received 9 July 2007).

NCT01337687 {published data only}

1. NCT01337687. Intranasal oxytocin for the treatment of autism spectrum disorders (INOT) [Intranasal oxytocin for the treatment of autism spectrum disorders].clinicaltrials.gov/ct2/show/NCT01337687 (first received 19 April 2011).

NCT01624675 {published data only}

1. NCT01624675. A study to evaluate the efficacy and safety of risperidone (R064766) in children and adolescents with irritability associated with autistic disorder [A double-blind, placebo-controlled study, followed by an open-label extension study evaluating the efficacy and safety of risperidone (r064766) in children and adolescents with irritability associated with autistic disorder].clinicaltrials.gov/ct2/show/NCT01624675 (first received 21 June 2012).

NCT01908205 {published data only}

1. NCT01908205. Intranasal oxytocin for the treatment of children and adolescents with autism spectrum disorders (ASD) (OXY-R) [Intranasal oxytocin for the treatment of children and adolescents with autism].clinicaltrials.gov/ct2/show/NCT01908205 (first received 25 July 2013).

NCT01972074 {published data only}

1. NCT01972074. Behavioral and neural response to memantine in adolescents with autism spectrum disorder.clinicaltrials.gov/ct2/show/NCT01972074 (first received 30 October 2013).

NCT02940574 {published data only}

1. NCT02940574. Neural and behavioral effects of oxytocin in autism spectrum disorders [Oxytocin-based pharmacotherapy for autism spectrum disorders: investigating the neural and behavioral effects of a promising intervention approach].clinicaltrials.gov/ct2/show/NCT02940574 (first received 21 October 2016).

NCT03242772 {published data only}

1. Impact of combined medication and behavioral treatment for ASD & ADHD.clinicaltrials.gov/ct2/NCT03242772?term=NCT03242772&draw=2&rank=1 (first received 14 December 2018).

Niederhofer 2002 {published data only}

1. Niederhofer H, Staffen W, Mair A. Lofexidine In hyperactive and impulsive children with autistic disorder. Journal of the American Academy of Child & Adolescent Psychiatry 2002;41(12):1396-7. [DOI: 10.1097/00004583-200212000-00010] [PMID: ] - DOI - PubMed

Niederhofer 2003 {published data only}

1. Niederhofer H, Staffen W, Mair A. Tianeptine: a novel strategy of psychopharmacological treatment of children with autistic disorder. Human Psychopharmacology 2003;18(5):389-93. [DOI: 10.1002/hup.491] [PMID: ] - DOI - PubMed

Nikoo 2015 {published data only}IRCT201110281556N29

1. IRCT201110281556N29. N-acetylcysteine in the treatment of autism [N-acetyl cysteine added to risperidone in the treatment of autism: a double blind and placebo controlled trial].en.irct.ir/trial/879 (first received 29 October 2011).
1. Nikoo M, Radnia H, Farokhnia M, Mohammadi M-R, Akhondzadeh S. N-acetylcysteine as an adjunctive therapy to risperidone for treatment of irritability in autism: a randomized, double-blind, placebo-controlled clinical trial of efficacy and safety. Clinical Neuropharmacology 2015;38(1):11-7. [DOI: 10.1097/WNF.0000000000000063] [PMID: ] - DOI - PubMed

Nikvarz 2017 {published data only}IRCT201204037202N5

1. IRCT201204037202N5. Comparing efficacy and side effects of memantine and risperidone in treating autistic patients.www.irct.ir/trial/7627 (first received 20 June 2012).
1. Nikvarz N, Alaghband-Rad J, Tehrani-Doost M, Alimadadi A, Ghaeli P. Comparing efficacy and side effects of memantine vs risperidone in the treatment of autistic disorder. Pharmacopsychiatry 2017;50(1):19-25. [DOI: 10.1055/s-0042-108449] [PMID: ] - DOI - PubMed

Owen 2009 {published data only}EUCTR2016‐005111‐40

1. EUCTR2016-005111-40. Study of aripiprazole in the treatment of serious behavioral problems in children and adolescents with autistic disorder (AD) [A multicenter, double-blind, randomized, placebo-controlled, flexible-dosed parallel-group study of aripiprazole flexibly dosed in thetreatment of children and adolescents with autistic disorder].www.clinicaltrialsregister.eu/ctr-search/trial/2016-005111-40/results (first received 7 April 2017).
1. Lewis D, Couch D, Marcus R, Manos G, Mankoski R, Carson W, et al. Efficacy and safety of flexibly-dosed aripiprazole for the treatment of irritability associated with autistic disorder in children and adolescents (6-17 years). Annals of Neurology 2009;66:S110-1. [DOI: 10.1002/ana.21853] - DOI
1. Lewis D, Owen R, Couch D. Efficacy and safety of aripiprazole for the treatment of irritability associated with autistic disorder in children and adolescents (6-17 years): results from two 8-week randomized, double-blind, placebo-controlled trials. Neurology 2009;72(11 (Supp 3)):A428. [ABSTRACT NO: S50.005]
1. Mankoski R, Stockton G, Manos G, Marlor S, McQuade R, Forbes RA, et al. Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. Journal of Child and Adolescent Psychopharmacology 2013;23(8):572-6. [DOI: 10.1089/cap.2012.0075] [PMCID: PMC3804231] [PMID: ] - DOI - PMC - PubMed
1. NCT00365859. Study of aripiprazole in the treatment of serious behavioral problems in children and adolescents with autistic disorder (AD) [A 52-week, open-label, multicenter study of the safety and tolerability of aripiprazole flexibly dosed in the treatment of children and adolescents with autistic disorder].clinicaltrials.gov/ct2/show/NCT00365859 (first received 18 August 2006).

Owley 2001 {published data only}

1. Owley T, Macmahon W, Cook EH, Laulhere T, South M, Mays LZ, et al. Multisite, double-blind, placebo-controlled trial of porcine secretin in autism. Journal of the American Academy of Child and Adolescent Psychiatry 2001;40(11):1293-9. [DOI: 10.1097/00004583-200111000-00009] [PMID: ] - DOI - PubMed

Parker 2017 {published data only}

1. NCT01624194. Intranasal oxytocin treatment for social deficits in children with autism [Double-blind, randomized, placebo controlled trial of intranasal oxytocin treatment for social deficits in children with autism].clinicaltrials.gov/ct2/show/NCT01624194 (first received 20 June 2012).
1. Parker KJ, Oztan O, Libove RA, Sumiyoshi RD, Jackson LP, Karhson DS, et al. Intranasal oxytocin treatment for social deficits and biomarkers of response in children with autism. Proceedings of the National Academy of Sciences of the United States of America 2017;114(30):8119‐24. [DOI: 10.1073/pnas.1705521114] [PMCID: PMC5544319] [PMID: ] - DOI - PMC - PubMed

Parker 2019 {published data only}

1. NCT01962870. The role of vasopressin in the social deficits of autism [Randomized placebo-controlled trial of vasopressin treatment for social deficits in children with autism].clinicaltrials.gov/ct2/show/NCT01962870 (first receceived 14 October 2013).
1. Parker KJ, Oztan O, Libove RA, Mohsin N, Karhson DS, Sumiyoshi RD, et al. A randomized placebo-controlled pilot trial shows that intranasal vasopressin improves social deficits in children with autism. Science Translational Medicine 2019;11(491):eaau7356. [DOI: 10.1126/scitranslmed.aau7356] [PMCID: PMC6716148] [PMID: ] - DOI - PMC - PubMed

Pearson 2013 {published data only}

1. NCT00178503. Methylphenidate for attention deficit hyperactivity disorder and autism in children [ADHD symptoms in autism: cognition, behavior, treatment].www.clinicaltrials.gov/ct2/show/NCT00178503 (first received 15 September 2005).
1. Pearson DA, Santos CW, Aman MG, Arnold LE, Casat CD, Mansour R, et al. Effects of extended release methylphenidate treatment on ratings of attention-deficit/hyperactivity disorder (ADHD) and associated behavior in children with autism spectrum disorders and ADHD symptoms. Journal of Child and Adolescent Psychopharmacology 2013;23(5):337-51. [DOI: 10.1089/cap.2012.0096] [PMCID: PMC3689935] [PMID: ] - DOI - PMC - PubMed

Posey 2005 {published data only (unpublished sought but not used)}

1. NCT00025779. Methylphenidate in children and adolescents with pervasive developmental disorders [Methylphenidate for hyperactivity and impulsiveness in children and adolescents with pervasive developmental disorders].clinicaltrials.gov/ct2/show/NCT00025779 (first received 24 October 2001).
1. Research Units on Pediatric Psychopharmacology (RUPP) Autism Network. Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Archives of General Psychiatry 2005;62(11):1266-74. [DOI: 10.1001/archpsyc.62.11.1266] [PMID: ] - DOI - PubMed
1. Scahill L, Bearss K, Sarhangian R, McDougle CJ, Arnold LE, Aman MG, et al. Using a patient-centered outcome measure to test methylphenidate versus placebo in children with autism spectrum disorder. Journal of Child and Adolescent Psychopharmacology 2017;27(2):125-31. [DOI: 10.1089/cap.2016.0107] [PMCID: PMC5367913] [PMID: ] - DOI - PMC - PubMed

Quintana 1995 {published data only}

1. Quintana H, Birmaher B, Stedge D, Lennon S, Freed J, Bridge J, et al. Use of methylphenidate in the treatment of children with autistic disorder. Journal of Autism and Developmental Disorders 1995;25(3):283-94. [DOI: 10.1007/BF02179289] [PMID: ] - DOI - PubMed

Remington 2001 {published data only (unpublished sought but not used)}

1. Remington G, Sloman L, Konstantareas M, Parker K, Gow R. Clomipramine versus haloperidol in the treatment of autistic disorder: a double-blind, placebo-controlled, crossover study. Journal of Clinical Psychopharmacology 2001;21(4):440-4. [DOI: 10.1097/00004714-200108000-00012] [PMID: ] - DOI - PubMed
1. Sloman L, Remington G, Konstantareas M, Parker K. Haloperidol versus clomipramine in autistic disorder. In: 151st Annual Meeting of the American Psychiatric Association; 1998 May 30 to June 4; Toronto (ON), Canada. Vol. 17. 1998. [PRESENTATION NO: 17]

Research Units 2005 {published data only}

1. Research Units on Pediatric Psychopharmacology Autism Network. Risperidone treatment for autistic disorder: longer-term benefits and blinded discontinuation after 6 months. American Journal of Psychiatry 2005;162(7):1361-9. [DOI: 10.1176/appi.ajp.162.7.1361] [PMID: ] - DOI - PubMed

Rezaei 2010 {published data only}IRCT138901141556N9

1. IRCT138901141556N9. Topiramate in the treatment of autism [Tpoiramate added to risperidone in patint with autistic disorder: a double-blind placebo controlled trial].www.irct.ir/trial/859 (first received 29 April 2010).
1. Rezaei V, Mohammadi M-R, Ghanizadeh A, Sahraian A, Tabrizi M, Rezazadeh S-A, et al. Double-blind, placebo-controlled trial of risperidone plus topiramate in children with autistic disorder. Progress in Neuro-Psychopharmacology and Biological Psychiatry 2010;34(7):1269-72. [DOI: 10.1016/j.pnpbp.2010.07.005] [PMID: ] - DOI - PubMed

Scahill 2015 {published data only}

1. Munoz Martinez V, Nuevo Fernandez L, Mella Dominguez L, Mata Saenz B, Asensio Aguerri L. Guanfacine as an alternative for autism spectrum disorder with hyperactivity symptoms. European Neuropsychopharmacology 2017;27(4):S607. [DOI: 10.1016/S0924-977X(17)31154-9] [POSTER NO: P.1.c.006] - DOI
1. NCT01238575. Guanfacine for the treatment of hyperactivity in pervasive developmental disorder.clinicaltrials.gov/ct2/show/NCT01238575 (first received 10 November 2010).
1. Politte LC, Scahill L, Figueroa J, McCracken JT, King B, McDougle CJ. A randomized, placebo-controlled trial of extended-release guanfacine in children with autism spectrum disorder and ADHD symptoms: an analysis of secondary outcome measures. Neuropsychopharmacology 2018;43(8):1772-8. [DOI: 10.1038/s41386-018-0039-3] [PMCID: PMC6006142] [PMID: ] - DOI - PMC - PubMed
1. Scahill L, McCracken JT, King BH, Rockhill C, Shah B, Politte L, et al. Extended-release guanfacine for hyperactivity in children with autism spectrum disorder. American Journal of Psychiatry 2015;172(12):1197-206. [DOI: 10.1176/appi.ajp.2015.15010055] [PMID: ] - DOI - PubMed

Shea 2004 {published data only}

1. Light M, Dunbar E, Shea S. P2.104 Efficacy and safety of risperidone in the treatment of children with autistic and other pervasive developmental disorders (PDD): a randomized, double-blind, placebo controlled trial. European Neuropsychopharmacology 2004;14(Suppl 3):S278. [DOI: 10.1016/S0924-977X(04)80324-9] - DOI
1. Light M, Dunbar F, Shea M. Efficacy and safety of risperidone in the treatment of children with autistic and other pervasive developmental disorders (PDD): a randomized, double-blind, placebo controlled trial. International Journal of Neuropsychopharmacology 2004;7:S275. [DOI: 10.1016/S0924-977X(04)80324-9] - DOI
1. Pandina GJ, Bossie CA, Youssef E, Zhu Y, Dunbar F. Risperidone improves behavioural symptoms in children with autism in a randomized, double-blind, placebo-controlled trial. Journal of Autism and Developmental Disorders 2007;37(2):367-73. [DOI: 10.1007/s10803-006-0234-7] [PMID: ] - DOI - PubMed
1. Shea S, Turgay A, Carroll A, Schulz M, Orlik H, Smith I, et al. Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics 2004;114(5):e634-41. [DOI: 10.1542/peds.2003-0264-F] [PMID: ] - DOI - PubMed

Sikich 2013 {published data only}

1. NCT01944046. Study of oxytocin in autism to improve reciprocal social behaviours (SOARS-B) [Phase II study of oxytocin in autism to improve reciprocal social behaviors].clinicaltrials.gov/ct2/show/NCT01944046 (first received 17 September 2013).
1. Sikich L, Alderman C, Hazzard L, Bethea T, Gregory S, Johnson J. Pilot study of sustained oxytocin treatment in children and adolescents with autistic disorder. Biological Psychiatry 2013;73(9):145S.

Sikich 2021 {published data only}

1. NCT01944046. Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors (SOARS-B).clinicaltrails.gov/ct2/show/study/NCT01944046?term=NCT01944046&draw=2&ra... (first received 1 August 2014).
1. Sikich L, Kolevzon A, King B, McDougle C, Sanders K, Kim S-J, et al. Intranasal oxytocin in children and adolescents with autism spectrum disorder. New England Journal of Medicine 2021;385(16):1462-73. [DOI: 10.1056/NEJMoa2103583] [PMID: ] - DOI - PMC - PubMed
1. Spanos M, Bethea T, Alderman C, Johnson J, Chandrasekhar T, Sikich L. Randomized, placebo-controlled trial with open-label extension of intranasal oxytocin for autism spectrum disorder. Journal of the American Academy of Child and Adolescent Psychiatry 2021;60(10):S162. [DOI: 10.1016/j.jaac.2021.09.087] - DOI

Soorya 2021 {published data only}

1. NCT01372449. A multi-site double-blind placebo-controlled trial of memantine versus placebo in children with autism (MEM).clinicaltrials.gov/ct2/show/NCT01372449?term=NCT01372449&draw=1&rank=1 (first received December 2011).
1. Soorya L, Fogg L, Ocampo E, Printen M, Youngkin S, Halpern D, et al. Neurocognitive outcomes from memantine: a pilot, double-blind, placebo-controlled trial in children with autism spectrum disorder. Journal of Child and Adolescent Psychopharmacology 2021;31(7):475-84. [DOI: 10.1089/cap.2021.0010] [PMID: ] - DOI - PubMed

Sprengers 2021 {published data only}

1. Sprengers J, Van Andel D, Zuithoff N, Keijzer-Veen M, Scheepers F, Lilien M, et al. Bumetanide versus placebo for core symptoms of autism spectrum disorder at 91 days (BAMBI): a single-centre, double-blinded, patient-randomized, placebo-controlled, phase-2-trial. European Neuropsychopharmacology 2020;40:S80-S81. [DOI: 10.1016/j.euroneuro.2020.09.108] - DOI - PubMed
1. Sprengers JJ, Van Andel DM, Zuithoff NP, Keijzer-Veen MG, Schulp AJ, Scheepers FE, et al. Bumetanide for core symptoms of autism spectrum disorder (BAMBI): a single center, double-blinded, participant-randomized, placebo-controlled, phase-2 superiority trial. Journal of the American Academy of Child and Adolescent Psychiatry 2021;60(7):865-76. [DOI: 10.1016/j.jaac.2020.07.888] [PMID: ] - DOI - PubMed

Squassante 2018 {published data only}

1. NCT01793441. A study of RG7314 to investigate efficacy and safety in individuals with autism spectrum disorders (ASD) [A multi-center, randomized, double-blind, 12-week, parallel group, placebo-controlled proof of concept study to investigate the efficacy and safety of rg7314 in individuals with autism spectrum disorders (ASD)].clinicaltrials.gov/ct2/show/NCT01793441 (first received 15 February 2013).
1. Squassante L, Bolognani F, Smith J, Murtagh L, Fontoura P, Khwaja O, et al. Effects of balovaptan on health-related quality of life of adult men with ASD: results from a phase 2 randomized double-blind placebo controlled study (Vanilla). Journal of the American Academy of Child and Adolescent Psychiatry 2018;57(10):S231. [DOI: 10.1016/j.jaac.2018.09.308] [PRESENTATION NO: 5.13] - DOI

Takamitsu 2015a {published data only}UMIN000007122

1. UMIN000007122. A randomized, double-blind and cross-over trial to examine effects of continuous administration of intranasal oxytocin on social dysfunction in subjects with autism spectrum disorders.center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008388 (first received 1 February 2012).
1. Watanabe T, Kuroda M, Kuwabara H, Aoki Y, Iwashiro N, Tatsunobu N, et al. Clinical and neural effects of six-week administration of oxytocin on core symptoms of autism. Brain 2015;138(11):3400-12. [DOI: 10.1093/brain/awv249] [PMID: ] - DOI - PubMed

Troost 2005 {published data only}

1. Malone RP. Discontinuing risperidone results in relapse in children with autism spectrum disorders. Evidence-Based Mental Health 2006;9(2):56. [DOI: 10.1136/ebmh.9.2.56] [PMID: ] - DOI - PubMed
1. Troost PW, Althaus M, Lahuis BE, Buitelaar JK, Minderaa RB, Hoekstra PJ. Neuropsychological effect of risperidone in children with pervasive developmental disorders: a blinded discontinuation study. Journal of Child and Adolescent Psychopharmacology 2006;16(5):561-73. [DOI: 10.1089/cap.2006.16.561] [PMID: ] - DOI - PubMed
1. Troost PW, Lahuis BE, Steenhuis M-P, Ketelaars CE, Buitelaar JK, Van Engeland H, et al. Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study. Journal of the American Academy of Child and Adolescent Psychiatry 2005;44(11):1137-44. [DOI: 10.1097/01.chi.0000177055.11229.76] [PMID: ] - DOI - PubMed

Umbricht 2017 {published data only}

1. NCT01474278. A study of RO5028442 in adult male high-functioning autistic patients.https://clinicaltrials.gov/ct2/show/NCT01474278?term=NCT01474278&draw=2&... (first registered December 2011).
1. Umbricht D, Del Valle Rubido M, Hollander E, McCracken JT, Shic F, Scahill L, et al. A single dose, randomized, controlled proof-of-mechanism study of a novel vasopressin 1a receptor antagonist (RG7713) in high-functioning adults with autism spectrum disorder. Neuropsychopharmacology 2017;42(9):1914-23. [DOI: 10.1038/npp.2016.232] [PMCID: PMC5520775] [PMID: ] - DOI - PMC - PubMed

Unis 2002 {published data only}

1. NCT00065962. Secretin for the treatment of autism [Multisite controlled secretin trial in autism].clinicaltrials.gov/ct2/show/NCT00065962 (first received 5 August 2003).
1. Unis AS, Munson JA, Rogers SJ, Goldson E, Osterling J, Gabriels R, et al. A randomized, double-blind, placebo-controlled trial of porcine versus synthetic secretin for reducing symptoms of autism. Journal of the American Academy of Child and Adolescent Psychiatry 2002;41(11):1315-21. [DOI: 10.1097/00004583-200211000-00012] [PMID: ] - DOI - PubMed

VanAndel 2022 {published data only}

1. VanAndel D, Sprengers J, Keijzer-Veen M, Schulp A, Lillien M, Scheepers F, et al. Bumetanide for irritability in children with sensory processing problems across neurodevelopmental disorders: a pilot randomized controlled trial. Frontiers in Psychiatry 2022;13:780281. [DOI: 10.3389/fpsyt.2022.780281] [PMID: ] - DOI - PMC - PubMed

Veenstra‐VanderWeele 2017 {published data only}

1. NCT01288716. Study of arbaclofen for the treatment of social withdrawal in subjects with autism spectrum disorders.https://clinicaltrials.gov/ct2/show/NCT01288716?term=NCT01288716&draw=2&... (first received February 2011).
1. Veenstra-VanderWeele J, Cook EH, King BH, Zarevics P, Cherubini M, Walton-Bowen K, et al. Arbaclofen in children and adolescents with autism spectrum disorder: a randomized, controlled, phase 2 trial. Neuropsychopharmacology 2017;42(7):1390-8. [DOI: 10.1038/npp.2016.237] [PMCID: PMC5436109] [PMID: ] - DOI - PMC - PubMed

Wasserman 2006 {published data only (unpublished sought but not used)}

1. Wasserman S, Iyengar R, Chaplin WF, Watner D, Waldoks SE, Anagnostou E, et al. Levetiracetam versus placebo in childhood and adolescent autism: a double-blind placebo-controlled study. International Clinical Psychopharmacology 2006;21(6):363-7. [DOI: 10.1097/01.yic.0000224787.13782.0f] [PMID: ] - DOI - PubMed

Willemsen‐Swinkels 1995 {published data only}

1. Willemsen-Swinkels SH, Buitelaar JK, Nijhof GJ, Van Engeland H. Failure of naltrexone hydrochloride to reduce self-injurious and autistic behaviour in mentally retarded adults. Double-blind placebo-controlled studies. Archives of General Psychiatry 1995;52(9):766-73. [DOI: 10.1001/archpsyc.1995.03950210060011] [PMID: ] - DOI - PubMed

Willemsen‐Swinkels 1996 {published data only}

1. Willemsen-Swinkels SH, Buitelaar JK, Van Engeland H. The effects of chronic naltrexone treatment in young autistic children: a double-blind placebo-controlled crossover study. Biological Psychiatry 1996;39(12):1023-31. [DOI: 10.1016/0006-3223(95)00297-9] [PMID: ] - DOI - PubMed

Wink 2016 {published data only}

1. NCT00453180. A study of oral N-acetylcysteine in children with autism spectrum disorders.https://clinicaltrials.gov/ct2/show/NCT00453180?term=NCT00453180&draw=2&... (first received March 2007).
1. Wink LK, Adams R, Wang Z, Klaunig JE, Plawecki MH, Posey DJ, et al. A randomized placebo-controlled pilot study of N-acetylcysteine in youth with autism spectrum disorder. Molecular Autism 2016;7:26. [DOI: 10.1186/s13229-016-0088-6] [PMCID: PMC4839099] [PMID: ] - DOI - PMC - PubMed

Wink 2018 {published data only}

1. NCT02081027. Pilot study of riluzole for drug-refractory irritability in autism spectrum disorders.https://clinicaltrials.gov/ct2/show/NCT02081027?term=NCT02081027&draw=2&... (first received March 2014). - PubMed
1. Wink LK, Adams R, Horn PS, Tessier CR, Bantel AP, Hong M, et al. A randomized placebo-controlled cross-over pilot study of riluzole for drug-refractory irritability in autism spectrum disorder. Journal of Autism and Developmental Disorders 2018;48(9):3051-60. [DOI: 10.1007/s10803-018-3562-5] [PMID: ] - DOI - PubMed

Woodard 2007 {published data only}

1. Woodard C, Groden J, Goodwin M, Bodfish J. A placebo double-blind pilot study of dextromethorphan for problematic behaviors in children with autism. Autism 2007;11(1):29-41. [DOI: 10.1177/1362361307070989] [PMID: ] - DOI - PubMed

Yamasue 2020 {published data only}

1. JPRN‐UMIN000015264. A multicenter, parallel group, placebo-controlled, double blind, confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders.https://trialsearch.who.int/Trial2.aspx?TrialID=JPRN-UMIN000015264 (first received March 2019).
1. Yamasue H, Okada T, Munesue T, Kuroda M, Fujioka T, Uno Y, et al. Effect of intranasal oxytocin on the core social symptoms of autism spectrum disorder: a randomized clinical trial. Molecular Psychiatry 2020;25(8):1849-58. [DOI: 10.1038/s41380-018-0097-2] [PMID: ] - DOI - PubMed

References to studies excluded from this review

Althaus 2015 {published data only}

1. Althaus M, Groen Y, Wijers A, Noltes H, Tucha O, Hoekstra P. Oxytocin enhances orienting to social information in a selective group of high-functioning male adults with autism spectrum disorder. Neuropsychologia 2015;79:53-69. [DOI: 10.1016/j.neuropsychologia.2015.10.025] - DOI - PubMed

Aman 1997 {published data only}

1. Aman M, Van Bourgondien M, Osborne P, Sarphare G. Side effects associated with psychoactive medication in individuals with autism. Journal of Autism & Developmental Disorders 1997;27(3):342-4. - PubMed

Aman 2009 {published data only}

1. Aman M, McDougle C, Scahill L, Handen B, Arnold L, Johnson C. Medication and parent training in children with pervasive developmental disorders and serious behavior problems: results from a randomized clinical trial. Journal of the American Academy of Child and Adolescent Psychiatry 2009;48(12):1143-54. [ISSN: 0890-8567] - PMC - PubMed

Anderson 1984 {published data only}

1. Anderson L, Campbell M, Grega D. Haloperidol in the treatment of infantile autism: Effects on learning and behavioral symptoms. American Journal of Psychiatry 1984;141(10):1195-202. - PubMed

Anderson 1989 {published data only}

1. Anderson L, Campbell M, Adams P, Small A, Perry R, Shell J. The effects of haloperidol on discrimination learning and behavioral symptoms in autistic children. Journal of Autism and Developmental Disorders 1989;19(2):227-39. - PubMed

Anderson 1997 {published data only}

1. Anderson S, Hanson R, Malecha M, Oftelie A, Erickson C, Clark J. The effectiveness of naltrexone in treating task attending, aggression, self-injury and stereotypic mannerisms of six young males with autism or pervasive developmental disorders. Journal of Developmental and Physical Disabilities 1997;9(3):211-42.

Anderson 2007 {published data only}

1. Anderson G, Scahill L, McCracken J, Aman M, Tierney E, Arnold L. Effects of short- and long-term risperidone treatment on prolactin levels in children with autism. Biological Psychiatry 2007;61(4):515-50. [DOI: ] - PubMed

Arman 2003 {published data only}

1. Arman A, Yazgan Y, Berkem M, Campbell M. The effects of risperidone on behaviors seen in children with pervasive developmental disorder and mental retardation in an educational setting. Bulletin of Clinical Psychopharmacology 2003;13(4):174-8.

Arnold 2012b {published data only}

1. Arnold L, Aman M, Li X, Butter E, Humphries K, Scahill L. Research Units of Pediatric Psychopharmacology (RUPP) autism network randomized clinical trial of parent training and medication: one-year follow-up. Journal of the American Academy of Child and Adolescent Psychiatry 2012;51(11):1173-84. [DOI: 10.1016/j.jaac.2012.08.028] - DOI - PMC - PubMed

August 1987 {published data only}

1. August G, Raz N, Baird T. Fenfluramine response in high and low functioning autistic children. Journal of the American Academy of Child & Adolescent Psychiatry 1985;26(3):342-6. [DOI: 10.1097/00004583-198705000-00011] - DOI - PubMed

Bachmann 2013 {published data only}

1. Bachmann C, Manthey T, Kamp-Becker I, Glaeske G, Hoffmann F. Psychopharmacological treatment in children and adolescents with autism spectrum disorders in Germany. Research in Developmental Disabilities 2013;34(9):2551-63. [DOI: 10.1016/j.ridd.2013.05.028] - DOI - PubMed

Barnard‐Brak 2016 {published data only}

1. Barnard-Brak L, Davis T, Schmidt M, Richman D. Effects associated with on- and off-label stimulant treatment of core autism and ADHD symptoms exhibited by children with autism spectrum disorder. Developmental neurorehabilitation 2016;19(1):46-53. [DOI: ] [PMID: ] - PubMed

Beeghly 1987 {published data only}

1. Beeghly J, Kuperma S, Perry P, Wright G, Tsai L. Fenfluramine treatment of autism: relationship of treatment response to blood levels of fenfluramine and norfenfluramine. Journal of Autism and Developmental Disorders 1987;17(4):541-8. [DOI: 10.1007/BF01486969] - DOI - PubMed

Castellanos 2019 {published data only}

1. Castellanos F. A placebo-controlled double-blind trial of cannabinoids in children and adolescents with autism spectrum disorder. Neuropsychopharmacology 2019;44(1):61-2. [DOI: 10.1038/s41386-019-0544-z] - DOI

Chez 2002 {published data only}

1. Chez M, Buchanan C, Aimonovitch M, Becker M, Schaefer K, Black C. Double-blind, placebo-controlled study of L-carnosine supplementation in children with autistic spectrum disorders. Journal of Child Neurology 2002;17(11):833-7. [DOI: 10.1177/08830738020170111501] - DOI - PubMed

Chez 2003 {published data only}

1. Chez M, Buchanan T, Becker M, Jessler J, Aimonovitch M, Mrazek S. Donepezil hydrochloride: a double-blind study in autistic children. Journal of Pediatric Neurology 2003;1(2):83-8. [DOI: 10.1055/s-0035-1557175] - DOI

Du 2015 {published data only}

1. Du L, Shan L, Wang B, Li H, Xu Z, Staal W. A pilot study on the combination of applied behavior analysis and bumetanide treatment for children with autism. Journal of Child and Adolescent Psychopharmacology 2015;25(7):585-8. [DOI: 10.1089/cap.2015.0045] - DOI - PubMed

Duker 1991 {published data only}

1. Duker P, Welles K, Seys D, Rensen H, Vis A, Berg G. Brief report: effects of fenfluramine on communicative, stereotypic, and inappropriate behaviors of autistic-type mentally handicapped individuals. Journal of Autism and Developmental Disorders 1991;21(3):355-63. [DOI: 10.1007/BF02207332] - DOI - PubMed

Dunn‐Geier 2000 {published data only}

1. Dunn-Geier J, Ho H, Auersperg E, Doyle D, Eaves L, Matsuba C. Effect of secretin on children with autism: a randomized controlled trial. Developmental Medicine and Child Neurology 2000;42(12):796-802. [DOI: 10.1017/S0012162200001481] [PMID: ] - DOI - PubMed

Ekman 1989 {published data only}

1. Ekman G, Miranda-Linne F, Gillberg C, Garle M, Wetterberg L. Fenfluramine treatment of twenty children with autism. Journal of Autism & Developmental Disorders 1989;19(4):511-32. [DOI: 10.1007/BF02212855] [PMID: ] - DOI - PubMed

Fahmy 2013 {published data only}

1. Fahmy S, El-Hamamsy M, Zaki O, Badary O. L-carnitine supplementation improves the behavioral symptoms in autistic children. Research in Autism Spectrum Disorders 2013;7(1):159-66. [DOI: 10.1016/j.rasd.2012.07.006] - DOI

Fang 2018 {published data only}

1. Fang L, Jiang X, Huang Y, Sun Y, Xie Y, Wang L. Efficacy of vitamin D combined with ω-3 fatty acid in treatment of children with autism spectrum disorder. Pharmaceutical Care and Research 2018;18(5):347-50. [DOI: 10.5428/pcar20180508] - DOI

Findling 1997a {published data only}

1. Findling R, Maxwell K, Scotese-Wojtila L, Huang J, Yamashita T, Wiznitzer M. High-dose pyridoxine and magnesium administration in children with autistic disorder: an absence of salutary effects in a double-blind, placebo-controlled study. Journal of Autism and Developmental Disorders 1997;27(4):467-78. [DOI: 10.1023/A:1025861522935] - DOI - PubMed

Groden 1987 {published data only}

1. Groden G, Groden J, Dondey, M, Zane T, Pueschel S. Effects of fenfluramine on the behavior of autistic individuals. Research in Developmental Disabilities 1987;8(2):203-11. - PubMed

Guglielmo 2013 {published data only}

1. Guglielmo R, Ioime L, Grandinetti P, Janiri L. Managing disruptive and compulsive behaviors in adult with autistic disorder with gabapentin. Journal of Clinical Psychopharmacology 2013;33(2):273-4. [DOI: 10.1097/JCP.0b013e318285680c] - DOI - PubMed

Handen 2013 {published data only}

1. Handen B, Johnson C, Butter E, Lecavalier L, Scahill L, Aman M. Use of a direct observational measure in a trial of risperidone and parent training in children with pervasive developmental disorders. Journal of Developmental & Physical Disabilities 2013;25(3):355-71. [DOI: 10.1007/s10882-012-9316-y] - DOI - PMC - PubMed

Hellings 2006a {published data only}

1. Hellings JA, Zarcone JR, Crandall K, Wallace D, Schroeder SR. Weight gain in a controlled study of risperidone in children, adolescents and adults with mental retardation and autism. Journal of Child and Adolescent Psychopharmacology 2001;11(3):228-38. [DOI: 10.1089/10445460152595559] [PMID: ] - DOI - PubMed
1. Hellings JA, Zarcone JR, Reese RM, Valdovinos MG, Marquis JG, Fleming KK, et al. A crossover study of risperidone in children, adolescents and adults with mental retardation. Journal of Autism and Developmental Disorders 2006;36(3):401-11. [DOI: 10.1007/s10803-006-0078-1] [PMID: ] - DOI - PubMed
1. Napolitano D. The effects of risperidone on the self-injury, aggression, and stereotypy of persons with developmental disabilities: observer agreement using direct observations and the aberrant behavior checklis during a double-blind placebo-controlled clinical. Dissertation Abstracts International: Section B: The Sciences and Engineering 2001;61(8-B):4384. [ISBN: 978-0-599-91735-4]
1. Zarcone JR, Hellings JA, Crandell K, Reese RM, Marquis J, Fleming K, et al. Effects of risperidone on aberrant behavior of persons with developmental disabilities: I. A double blind crossover study using multiple measures. American Journal of Mental Retardation 2001;106(6):525-38. [DOI: 10.1352/0895-8017(2001)106<0525:EOROAB>2.0.CO;2] [PMID: ] - DOI - PubMed

Hellings 2010 {published data only}

1. Hellings J, Cardona A, Schroeder S, Aman M, Buitelaar J, Findling R. Long-term safety and adverse events of risperidone in children, adolescents, and adults with pervasive developmental disorders. Journal of Mental Health Research in Intellectual Disabilities 2010;3(3):132-44.

Hellings 2015 {published data only}

1. Hellings J, Reid G, Cain S, Zhou X, Barth F, Aman M. Loxapine add-on for adolescents and adults with autism spectrum disorders and irritability. Journal of Child & Adolescent Psychopharmacology 2015;25(2):150-9. [DOI: 10.1089/cap.2014.0003] - DOI - PMC - PubMed

Hess 2010 {published data only}

1. Hess J, Matson J, Neal D, Mahan S, Fodstad J, Bamburg J. A comparison of psychotropic drug side effect profiles in adults diagnosed with intellectual disabilities and autism spectrum disorders. Journal of Mental Health Research in Intellectual Disabilities 2010;3(2):85-96. [DOI: 10.1080/19315861003690588] - DOI

Hollander 2003 {published data only}

1. Hollander E, Novotny S, Hanratty M, Yaffe R, DeCaria C, Aronowitz B. Oxytocin infusion reduces repetitive behaviors in adults with autistic and Asperger's disorders. Neuropsychopharmacology 2003;28(1):193-8. [DOI: 10.1038/sj.npp.1300021] - DOI - PubMed

Hollander 2006c {published data only}

1. Hollander E, Wasserman S, Swanson E, Chaplin W, Schapiro M, Zagursky K. A double-blind placebo-controlled pilot study of olanzapine in childhood/adolescent pervasive developmental disorder. Journal of Child and Adolescent Psychopharmacology October 2006;16(5):541-8. [DOI: 10.1089/cap.2006.16.541] - DOI - PubMed

Hollander 2020c {published data only}

1. Hollander E, Jacob S, Jou R, McNamara N, Sikich L, Tobe R. A phase 2 randomized controlled trial of balovaptan in pediatric participants with autism spectrum disorder. Journal of the American Academy of Child and Adolescent Psychiatry 2020;59(10):S262-S263. [DOI: 10.1016/j.jaac.2020.08.458] - DOI

Horovitz 2012 {published data only}

1. Horovitz M, Matson J, Barker A. The relationship between symptoms of autism spectrum disorders and psychotropic medication use in infants and toddlers. Research in Autism Spectrum Disorders 2013;6(4):1406-11. [DOI: 10.1016/j.rasd.2011.05.013] - DOI

Horrigan 1997 {published data only}

1. Horrigan J, Barnhill L. Risperidone and explosive aggressive autism. Journal of Autism & Developmental Disorders 1997;27(3):313-23. [DOI: 10.1023/A:1025854532079] - DOI - PubMed

Hughes 2002 {published data only}

1. Hughes D, Cunningham M, Libretto S. Risperidone in children and adolescents with autistic disorder and aggressive behaviour. British Journal of Developmental Disabilities 2002;48(95):113-22. [DOI: 10.1179/096979502799104229] - DOI

Jacob 2020 {published data only}

1. Jacob S, Veenstra-VanderWeele J, Murphy D, McCracken J, Smith J. Phase 3 randomized controlled trial of balovaptan in adults with autism spectrum disorder. Journal of the American Academy of Child and Adolescent Psychiatry 2020;59(10):S163-S164. [DOI: 10.1016/j.jaac.2020.08.108] - DOI

Jordan 2012 {published data only}

1. Jordan I, Robertson D, Catani M, Craig M, Murphy D. Aripiprazole in the treatment of challenging behaviour in adults with autism spectrum disorder. Psychopharmacology 2012;223(3):357-60. [DOI: 10.1007/s00213-012-2723-z] - DOI - PubMed

JPRN‐UMIN000007250 2012 {published data only}

1. JPRN-UMIN000007250. A randomized, double-blind, placebo-controlled, cross-over trial of oxytocin in patients with autism spectrum disorder.http://www.who.int/trialsearch/Trial2.aspx?TrialID=JPRN-UMIN000007250 2012. [http://www.who.int/trialsearch/Trial2.aspx?TrialID=JPRN-UMIN000007250]

Jun 2000 {published data only}

1. Jun S-S, Kao C-H, Lee Y-C. Double blind crossover study of secretin/secrepan treatment for children with autistic symptoms. Tzu Chi Medical Journal 2000;12(3):173-81.

Kolmen 1995 {published data only}

1. Kolmen B, Feldman H, Handen B, Janosky J. Naltrexone in young autistic children: a double-blind, placebo-controlled crossover study. Journal of the American Academy of Child and Adolescent Psychiatry 1995;34(2):223-31. [DOI: 10.1097/00004583-199502000-00018] - DOI - PubMed

Kolmen 1997 {published data only}

1. Kolmen B, Feldman H, Handen B, Janosky J. Naltrexone in young autistic children: replication study and learning measures. Journal of the American Academy of Child and Adolescent Psychiatry 1997;36(11):1570-8. [DOI: 10.1016/S0890-8567(09)66567-9] - DOI - PubMed

Krusch 2004 {published data only}

1. Krusch D. Effects of repeated secretin administration on a subset of children with pervasive developmental disorder. Dissertation Abstracts International: Section B: The Sciences and Engineering 2004;65(2-B):1032. [ISBN: 9780496695942]

Leboyer 1993 {published data only}

1. Leboyer M, Bouvard M, Recasens J, Plumet M, Waller P, Tabuteau F. Opioid hypothesis in infantile autism? Therapeutic trials with naltrexone [Une hypothese opiacee dans l'autisme infantile? Essais therapeutiques avec la naltrexone]. Encephale 1993;19:95-102. - PubMed

Lemonnier 2012 {published data only}

1. Lemonnier E, Degrez C, Phelep M, Tyzio R, Josse R, Grandgeorge M. A randomised controlled trial of bumetanide in the treatment of autism in children. Translational Psychiatry 2012;2:e202. [DOI: 10.1038/tp.2012.124] - DOI - PMC - PubMed

Leventhal 1993 {published data only}

1. Leventhal B, Cook E, Morford M, Ravitz A, Heller W, Freedman D. Clinical and neurochemical effects of fenfluramine in children with autism. Journal of Neuropsychiatry and Clinical Neurosciences 1993;5(3):307-15. [DOI: 10.1176/jnp.5.3.307] - DOI - PubMed

Levine 1997 {published data only}

1. Levine J, Aviram A, Holan A, Ring A, Barak A, Belmaker R. Inositol treatment of autism. Journal of Neural Transmission 1997;104(2-3):307-10. - PubMed

Malone 2002 {published data only}

1. Malone R, Maislin G, Choudhrey M, Gifford. Risperidone treatment in children and adolescents with autism: short- and long-term safety and effectiveness. Journal of the American Academy of Child & Adolescent Psychiatry 2002;41(2):140-7. - PubMed

Moharreri 2017 {published data only}

1. IRCT201108155280N5. A comparative study on the effectiveness of risperidone versus risperidone plus naltrexone in treatment of autistic spectrum disorder in children with 6-12 years old.www.irct.ir/trial/5631 (first received 10 February 2013).
1. Moharreri F, Abdollahian E, Hosseini SA, Mirzadeh M. Comparative study on the effect of risperidone and its combination with naltrexone in pediatric patients with autistic spectrum disorders: a clinical trial study. International Journal of Pediatrics 2017;5(12):6375-82. [DOI: 10.22038/ijp.2017.18557.1516] - DOI

Nagaraj 2006 {published data only (unpublished sought but not used)}

1. Nagaraj R, Singhi P, Malhi P. Risperidone in children with autism: randomized, placebo-controlled, double-blind study. Journal of Child Neurology 2006;21(6):450-5. - PubMed

NCT00198120 2005 {published data only}

1. NCT00198120. Safety and effectiveness of D-Cycloserine in children with autism.https://clinicaltrials.gov/ct2/show/NCT00198120?term=NCT00198120&draw=2&... (first received February 2004).

NCT01078844 {published data only}

1. NCT01078844. Memantine in adult autism spectrum disorder.https://clinicaltrials.gov/study/NCT01078844 (not published - terminated) (first received 1 March 2010).

Nickels 2008 {published data only}

1. Nickels K, Katusic S, Colligan R, Weaver A, Voigt R, Barbaresi W. Stimulant medication treatment of target behaviors in children with autism: a population-based study. Journal of Developmental & Behavioral Pediatrics 2008;29(2):75-81. [DOI: 10.1097/DBP.0b013e31815f24f7] - DOI - PMC - PubMed

Niederhofer 2007 {published data only}

1. Niederhofer H. Glutamate antagonists seem to be slightly effective in psychopharmacologic treatment of autism. Journal of Clinical Psychopharmacology 2007;27(3):317-8. [DOI: 10.1097/01.jcp.0000270082.30500.69] - DOI - PubMed

Posey 2004 {published data only}

1. Posey D, Kem D, Swiezy N, Sweeten T, Wiegand R, McDougle C. A pilot study of D-cycloserine in subjects with autistic disorder. The American journal of psychiatry 2004;161(11):2115-7. [DOI: 10.1176/appi.ajp.161.11.2115] - DOI - PubMed

Preckel 2016 {published data only}

1. DRKS00008952. Oxytocin-induced enhancement of Social Skills Training in Adolescents with ASD.http://www.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00008952 2015 2015.
1. Mayer A, Preckel K, Ihle K, Piecha F, Junghanns K, Reiche S. No support for oxytocin modulation of reward-related brain function in autism: evidence from a randomized controlled trial.https://www.medrxiv.org/content/10.1101/2021.03.19.21253900v1 2021. [DOI: 10.1101/2021.03.19.21253900] - DOI
1. Preckel K, Kanske P, Singer T, Paulus F, Krach S. Clinical trial of modulatory effects of oxytocin treatment on higher-order social cognition in autism spectrum disorder: a randomized, placebo-controlled, double-blind and crossover trial. BMC Psychiatry 2016;16(1):329-39. [DOI: 10.1186/s12888-016-1036-x] - DOI - PMC - PubMed

Purdon 1994 {published data only}

1. Purdon S, Lit W, Labelle A, Jones B. Risperidone in the Treatment of Pervasive Developmental Disorder. Canadian Journal of Psychiatry 1994;39(7):400-05. - PubMed

Radzivil 2006 {published data only}

1. Radzivil M, Bashina V. An effect of long-term cerebrolysin therapy in combination with neuroleptics on behavioral and cognitive disturbances in endogenous childhood autism. Zhurnal Nevrologii i Psikhiatrii Imen 2006;106(2):21-5. [PMID: ] - PubMed

Ratcliff‐Schaub 2005 {published data only}

1. Ratcliff-Schaub K, Carey T, Reeves G, Rogers M. Randomized controlled trial of transdermal secretin on behavior of children with autism. the international journal of research and practice 2005;9(3):256-65. [PMID: ] - PubMed

Ritvo 1971 {published data only}

1. Ritvo E, Yuwiler A, Geller E, Kales E, Rashkis S, Schicor, A. Effects of L-dopa in autism. Journal of Autism & Childhood Schizophrenia 1971;1(2):190-205. - PubMed

Ritvo 1983 {published data only}

1. Ritvo E, Freeman B, Geller E, Yuwiler A. Effects of fenfluramine on 14 outpatients with the syndrome of autism. Journal of the American Academy of Child Psychiatry 1983;22(6):549-58. [DOI: 10.1097/00004583-198311000-00006] [PMID: ] - DOI - PubMed

Ritvo 1984 {published data only}

1. Ritvo E, Freeman B, Yuwiler, A, Geller E, Yokota A, Schroth P. Study of fenfluramine in outpatients with the syndrome of autism. The Journal of pediatrics 1984;105(5):823-8. - PubMed

Roberts 2001 {published data only}

1. Roberts W, Weaver L, Brian J, Bryson S, Emelianova S, Griffiths A. Repeated doses of porcine secretin in the treatment of autism: a randomized, placebo-controlled trial. Pediatrics 2001;107(5):E71. [DOI: 10.1542/peds.107.5.e71] - DOI - PubMed

Scifo 1996 {published data only}

1. Scifo R, Batticane N, Quattropani N, Spoto G. A double-blind trial with naltrexone in autism. Brain Dysfunction 1991;4(6):301-7.
1. Scifo R, Cioni M, Nicolosi A, Batticane N, Tirolo C, Testa N. Opioid-immune interactions in autism: behavioural and immunological assessment during a double-blind treatment with naltrexone. Annali dell'Istituto superiore di sanità 1996;32(3):351-9. - PubMed

Sponheim 2002 {published data only}

1. Sponheim E, Oftedal G, Helverschou S. Multiple doses of secretin in the treatment of autism: a controlled study. Acta paediatrica 2002;91(5):540-5. [DOI: 10.1111/j.1651-2227.2002.tb03274.x] - DOI - PubMed

Steiner 1999 {published data only}

1. Steiner M, Babcock S, Steinberg S, Stewart D, Carter D, Berger C. Fluoxetine's efficacy in improving physical symptoms associated with pdd: results from a multisite, randomized, placebo-controlled trial. Proceedings of the 152nd annual meeting of the American Psychiatric Association 1999:15-20.

Stubbs 1986 {published data only}

1. Stubbs E, Budden S, Jackson R, Terdal L, Ritvo E. Effects of fenfluramine on eight outpatients with the syndrome of autism. Developmental medicine and child neurology 1986;28(2):229-35. [DOI: 10.1111/j.1469-8749.1986.tb03859.x] [PMID: ] - DOI - PubMed

Sugie 2003 {published data only}

1. Sugie Y, Sugie H, Fukuda T, Ito M, Ohzeki T. Studies on the adverse effects of fluvoxamine treatment in children with autistic disorder: correlation with genetic polymorphism in serotonin related genes. No to Hattatsu [Brain & Development] 2003;35(3):233-7. - PubMed

Sugiyama 1998 {published data only (unpublished sought but not used)}

1. Sugiyama N, Sugie H, Igarashi Y, Ito M, Fukuda T. Low-dose levodopa therapy of autistic disorder: evaluation of clinical effectiveness. No to Hattatsu [Brain and Development] 1998;30(1):51-5. [ISSN: 0029-0831] - PubMed

Tachibana 2013 {published data only}

1. Tachibana M, Kagitani-Shimono K, Mohri I, Yamamoto T, Sanefuji W, Nakamura A. Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders. Journal of Child and Adolescent Psychopharmacology 2013;23(2):123-7. [DOI: 10.1089/cap.2012.0048] [PMID: ] - DOI - PubMed

Taylor 1993 {published data only}

1. Taylor D, Sandman C, Touchette P, Hetrick W, Barron J. Naltrexone improves learning and attention in self-injurious individuals with developmental disabilities. Pharmacotherapy 1993;5(1):29-42. [DOI: 10.1007/BF01046596] - DOI

Tolbert 1993 {published data only}

1. Tolbert L, Haigler T, Waits M, Dennis T. Fluoxetine in autism. Journal of Autism and Developmental Disorders 1993;23(1):193-9. [DOI: 10.1007/BF01066428] [PMID: ] - DOI - PubMed

Troost 2006 {published data only}

1. Troost P, Steenhuis M, Tuynman-Qua H, Kalverdijk L, Buitelaar J, Minderaa R. Atomoxetine for attention-deficit/hyperactivity disorder symptoms in children with pervasive developmental disorders: a pilot study. Journal of Child and Adolescent Psychopharmacology October 2006;16(5):611-19. [DOI: 10.1089/cap.2006.16.611] - DOI - PubMed

Volkmar 1983 {published data only}

1. Volkmar F, Paul R, Cohen D, Shaywitz B. Irritability in autistic children treated with fenfluramine. New England Journal of Medicine 1983;309(3):187. - PubMed

Volkmar 2009 {published data only}

1. Volkmar F. Citalopram treatment in children with autism spectrum disorders and high levels of repetitive behavior. Archives of General Psychiatry 2009;66(6):581-2. [DOI: 10.1001/archgenpsychiatry.2009.42] - DOI - PubMed

Wasserman 2005 {published data only}

1. Wasserman S. Divalproex sodium vs. placebo in the treatment of repetitive behaviors and the treatment of activation associated with fluoxetine in autism spectrum disorder. Biological Psychiatry 2005;57(8):166S-167S. [DOI: 10.1017/S1461145705005791] [PMID: ] - DOI - PubMed

Wei 2011 {published data only}

1. Wei B, Huang F, Qin X, Liang Q. Treatment of behavioral disorders by risperidone in children with autism. Zhongguo Dangdai Erke Zazhi 2011;13(3):216-8. - PubMed

Witwer 2005 {published data only}

1. Witwer A, Lecavalier L. Treatment incidence and patterns in children and adolescents with autism spectrum disorders. Journal of Child & Adolescent Psychopharmacology 2005;15(4):671-81. [PMID: ] - PubMed

Yarbrough 1987 {published data only}

1. Yarbrough E, Santat U, Perel I, Webster C, Lombardi R. Effects of fenfluramine on autistic individuals residing in a state developmental centre. Journal of autism and developmental disorders 1987;17(3):303-14. [DOI: 10.1007/BF01487062] - DOI - PubMed

Yui 2012 {published data only}

1. Yui K. Useful pharmacologic treatment in impaired social interaction in autism spectrum disorders. Seishin Shinkeigaku Zasshi - Psychiatria et Neurologia Japonica 2012;114(8):934-40. - PubMed

Zingarelli 1992 {published data only}

1. Zingarelli G, Ellman G, Hom A, Wymore M. Clinical effects of naltrexone on autistic behavior. American Journal on Mental Retardation 1992;97(1):57-63. - PubMed

References to studies awaiting assessment

Anagnostou 2018 {published data only}

1. Anagnostou E, Bennett TA, Thorpe K, Nicolson R. A phase 2 randomized, placebo-controlled trial of tideglusib, an orally administered GSK-3 beta inhibitor, in the treatment of adolescents with ASD. Journal of the American Academy of Child and Adolescent Psychiatry 2018;57(10):S232. [DOI: 10.1016/j.jaac.2018.09.311] - DOI

Buitelaar 1996 {published data only}

1. Buitelaar JK, Dekker ME, Van Ree JM, Van Engeland H. A controlled trial with ORG 2766, an ACTH-(4-9) analog, in 50 relatively able children with autism. European Neuropsychopharmacology 1996;6(1):13-9. [DOI: 10.1016/0924-977x(95)00049-u] [PMID: ] - DOI - PubMed

Campbell 1982a {published data only}

1. Campbell M, Anderson L, Cohen I. Haloperidol in autistic children: effects on learning, behavior, and abnormal involuntary movements. Psychopharmacology Bulletin 1982;18(1):110-11.

Carminati 2016 {published data only}

1. Carminati GG, Gerber F, Darbellay B, Kosel MM, Deriaz N, Chabert J, et al. Using venlafaxine to treat behavioral disorders in patients with autism spectrum disorder. Progress in Neuro-Psychopharmacology & Biological Psychiatry 2016;65:85-95. [DOI: 10.1016/j.pnpbp.2015.09.002] [PMID: ] - DOI - PubMed

Gabis 2019 {published data only}

1. Gabis LV, Ben-Hur R, Shefer S, Jokel A, Shalom DB. Improvement of language in children with autism with combined donepezil and choline treatment. Journal of Molecular Neuroscience 2019;69(2):224-34. [DOI: 10.1007/s12031-019-01351-7] [PMID: ] - DOI - PubMed
1. NCT01098383. Treatment with acetyl-choline esterase inhibitors in children with autism spectrum disorders [Treatment with acetyl-choline esterase inhibitors in children with autism ].clinicaltrials.gov/ct2/show/NCT01098383 (first received 2 April 2010).

Handen 2000 {published data only}

1. Handen BL, Johnson CR, Lubetsky M. Efficacy of methylphenidate among children with autism and symptoms of attention-deficit hyperactivity disorder. Journal of Autism and Developmental Disorders 2000;30(3):245-55. [DOI: 10.1023/A:1005548619694] [PMID: ] - DOI - PubMed

IRCT2017041333406N1 {published data only}IRCT2017041333406N1

1. IRCT2017041333406N1. The efficacy of augmentation donepezil to risperidon in treatment of autism spectrum disorders [Assessment the efficacy of augmentation donepezil to risperidon in treatment of autism spectrum disorders].www.irct.ir/trial/25769 (first received 20 September 2017).

IRCT20190714044199N1 {published data only}IRCT20190714044199N1

1. IRCT20190714044199N1. Efficacy of N-acetyl cysteine in patients with autism spectrum disorder [Evaluating the efficacy of adding N-acetyl cysteine to risperidone treatment regimen in patients with autism spectrum disorder].www.irct.ir/trial/41209 (first received 10 November 2019).

JPRN‐JMA‐IIA00438 {published data only}

1. JPRN-JMA-IIA00438. The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; exploratory physician-led Phase 2 trial.ww.trialsearch.who.int/Trial2.aspx?trialID=JPRN-JMA-IIA00438 (first received March 2020).

Jung 2000 {published data only}

1. Jung S, Lee Y. A double blind study of dimethylglycine treatment in children with autism. A double blind study of dimethylglycine treatment in children with autism 2000;12(2):111-21.

Jørgensen 2002 {published data only}

1. Jørgensen M, Thomsen PH, Henriksen JH. Secretin treatment of autism? Ugeskrift for Laeger 2002;164(12):1676. [PMID: ] - PubMed

Kern 2001a {published data only (unpublished sought but not used)}

1. Kern JK, Miller VS, Cauller L, Kendall R, Mehta J, Dodd M. Effectiveness of N,N-Dimethylglycine in autism and pervasive developmental disorder. Journal of Child Neurology 2000;16(3):169-73. [DOI: 10.2310/7010.2001.17515] [PMID: ] - DOI - PubMed

Kern 2002 {published data only}

1. Kern JK, Van Miller S, Evans PA, Travedi MH. Efficacy of porcine secretin in children with autism and pervasive developmental disorder. Journal of Autism and Developmental Disorders 2002;32(3):153-60. [DOI: 10.1023/A:1015441428154] [PMID: ] - DOI - PubMed

Li 2016 {published data only}

1. Li Y-C, Ma J, Xu H-M, Yang G-Y, Zhang J-C. Efficacy and safety of paliperidone and aripiprazole in the treatment of autism. Chinese Journal of New Drugs 2016;25(16):1893-7.

Malone 2010 {published data only}

1. Malone R, West S, Ghaffari M, Delaney M, Hardison H. Metabolic effects of olanzapine in children with autistic disorder. Journal of Child and Adolescent Psychopharmacology 2010;20(6):531-2. [DOI: 10.1089/cap.2010.2064] - DOI
1. NCT00057408. A controlled sudy of olanzapine in children with autism.clinicaltrials.gov/ct2/show/NCT00057408 (first received 2 April 2003).

Martsenkovsky 2016 {published data only}

1. Martsenkovsky I, Martsenkovska I. The safety and efficacy of memantine hydrochloride versus placebo for children under 3 years old with autism spectrum disorders. European Neuropsychopharmacology 2016;26(2):S729. [DOI: 10.1016/S0924-977X(16)31879-X] [EISSN: 1873-786] [ABSTRACT NO: P.7.d.002] - DOI

Miller 1979 {published data only}

1. Miller B, Wallis H. Mode of action of sulpiride in autistic children. A double blind study. Münchener Medizinische Wochenschrift 1979;121(19):667-9. [PMID: ] - PubMed

Molloy 2002 {published data only (unpublished sought but not used)}

1. Molloy CA, Manning-Courtney P, Swayne S, Bean J, Brown JM, Murray DS, et al. Lack of benefit of intravenous synthetic human secretin in the treatment of autism. Journal of Autism and Developmental Disorders 2002;32(6):545-51. [DOI: 10.1023/A:1021202930206] [PMID: ] - DOI - PubMed

Naruse 1982 {published data only}

1. Hyoka R. A multi centered double blind trial of pimozide (Orap), haloperidol and placebo for abnormal behavior in children using crossover design. Clinical Evaluation 1980;8(3):629-73.
1. Naruse H, Nagahata M, Nakane Y, Shirahashi K, Takesada M, Yamazaki K. A multi-center double-blind trial of pimozide (Orap), haloperidol and placebo in children with behavioral disorders, using crossover design. Acta Paedopsychiatrica 1982;48(4):173-84. [PMID: ] - PubMed

Noone 2014 {published data only}

1. Noone R, Ferretti C, Taylor B, Racine E, Hollander E. Milnacipran vs placebo in adult autism spectrum disorder: impact on hyperactivity. Neuropsychopharmacology 2014;39:S291-S472. [DOI: 10.1038/npp.2014.281] - DOI

Novotny 2004 {published data only (unpublished sought but not used)}

1. Novotny S, Hollander E, Phillips A, Allen A, Wasserman S, Iyengar R. Increased repetitive behaviours and prolactin responsivity to oral m-chlorophenylpiperazine in adults with autism spectrum disorders. International Journal of Neuropsychopharmacology 2004;7(3):249-54. [DOI: 10.1017/S146114570400433X] [PMID: ] - DOI - PubMed

Sandler 1999 {published data only (unpublished sought but not used)}

1. Sandler AD, Sutton KA, DeWesse J, Girardi MA, Sheppard V, Bodfish JW. Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder. New England Journal of Medicine 1999;341(24):1801-6. [DOI: 10.1056/NEJM199912093412404] [PMID: ] - DOI - PubMed

Stern 1990 {published data only (unpublished sought but not used)}

1. Stern LM, Walker MK, Sawyer MG, Oades RD, Badcock NR, Spence JG. A controlled crossover trial of fenfluramine in autism. Journal of Child Psychology and Psychiatry 1990;31(4):569-85. [DOI: 10.1111/j.1469-7610.1990.tb00798.x] [PMID: ] - DOI - PubMed

Wink 2020 {published data only}

1. NCT02611921. Study of intranasal ketamine for social impairment in autism spectrum disorder. Search of: NCT02611921 - List Results -ClinicalTrials.gov First received January 2021.
1. Wink L, Reisinger, DL, Horn P, Shaffer R, O'Brien K, Schmitt L. Brief Report: intranasal Ketamine in Adolescents and Young Adults with Autism Spectrum Disorder—Initial Results of a Randomized, Controlled, Crossover, Pilot Study. Journal of Autism and Developmental Disorders 2020;51(4):1392-99. [DOI: 10.1007/s10803-020-04542-z] [PMID: ] - DOI - PubMed

Yatawara 2016 {published data only}

1. Yatawara C, Einfeld S, Hickie I, Davenport T, Guastella A. The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial. Molecular Psychiatry September 2016;21(9):1225-31. [DOI: 10.1038/mp.2015.162] [PMID: 10.1038/mp.2015.162] - DOI - DOI - PMC - PubMed

References to ongoing studies

ACTRN12617000441314 {published data only}

1. ACTRN12617000441314. The feasibility of magnetic resonance imaging in a non-selective comprehensive clinical trial in pediatric autism spectrum disorder.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12617000441314 (first received in 2017).

ChiCTR1800017720 {published data only}

1. ChiCTR1800017720. A random, double-blind, placebo controlled trial for oxytocin nasal spray in the treatment for ASD social dysfunction.www.chictr.org.cn/showprojen.aspx?proj=29953 (first received 10 August 2018).

Crutel 2020 {published data only}

1. Crutel V, Lambert E, Penelaud P-F, Albarran Severo C, Fuentes J, Rosier A, et al. Bumetanide oral liquid formulation for the treatment of children and adolescents with autism spectrum disorder: design of two phase III studies (SIGN Trials). Journal of Autism and Developmental Disorders 2020;51(8):2959-72. [DOI: 10.1007/s10803-020-04709-8] [PMCID: PMC8254707] [PMID: ] - DOI - PMC - PubMed

CTRI/2021/12/038721 {published data only}

1. CTRI/2021/12/038721. Comparison of the efficacy of oral risperidone and aripiprazole in children with autism spectrum disorders (ASDs) aged 6-18 years: a double blind randomized controlled trial - RAAT.www.trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2021/12/038721 (first received December 2021).

EUCTR2008‐003712‐36‐FR {published data only}

1. EUCTR2008-003712-36-FR. Study of the clinical and neurofunctional response to fluoxetine in childhood autism (FAIR) [Etude de la réponse clinique et neurofonctionnelle à la fluoxétine dans l'autisme infantile (FAIR)].www.clinicaltrialsregister.eu/ctr-search/trial/2008-003712-36/FR (first received 19 June 2008).

EUCTR2010‐024202‐34‐DE {published data only}EUCTR2010‐024202‐34‐DE

1. EUCTR2010-024202-34-DE. Group-therapy, autism and oxytocin - an investigation with the question "Does oxytocin (OT) enhance therapy effects in autism?" [Effekt von oxytocin auf den therapieerfolg eines sozialen kompetenztrainings bei jugendlichen mit autismus-spektrum-störung (Effect of oxytocin on therapy results of a group based social skill training in adolescents with autism spectrum disorder)].www.clinicaltrialsregister.eu/ctr-search/trial/2010-024202-34/DE (first received 9 December 2013).

EUCTR2014‐003080‐‐38‐DE {published data only}EUCTR2014‐003080‐‐38‐DE

1. Häge A, Banaschewski T, Buitelaar JK, Dijkhuizen RM, Franke B, Lythgoe DJ, et al. Glutamatergic medication in the treatment of obsessive compulsive disorder (OCD) and autism spectrum disorder (ASD) – study protocol for a randomised controlled trial. Trials 2016;17(1):141. [DOI: 10.1186/s13063-016-1266-8] [PMCID: PMC4794817] [PMID: ] - DOI - PMC - PubMed

IRCT20090117001556N124 {published data only}IRCT20090117001556N124

1. IRCT20090117001556N124. Cilostazol in the treatment of autism [Cilostazol as adjunctive treatment of autism: a double blind and placebo controlled trial in children 5 to 11 years old cilostazol in the treatment of autism].www.irct.ir/trial/48108 (first received 16 May 2020).

IRCT20200317046801N2 {published data only}IRCT20200317046801N2

1. IRCT20200317046801N2. The effect of ondansetron on autism [Effect of ondansetron combination therapy with risperidone in children with autism spectrum disorder in a randomized, double-blind, placebo-controlled clinical trialThe effect of ondansetron on autism].www.irct.ir/trial/46589 (first received 13 April 2020).

ISRCTN15984604 {published data only}

1. ACTRN12621000801819. Sertraline for anxiety in adults with a diagnosis of autism (STRATA) a randomised controlled trial.Australianclinicaltrials.gov.au/anzctr/trial/ACTRN12621000801819 (first received 9 February 2022).
1. ISRCTN15984604. Sertraline for anxiety in adults with a diagnosis of autism.www.isrtcn.com/ISRTCN15984604.

JPRN‐UMIN000017876 {published data only}

1. UMIN000017876. Effects of long-term administration of intranasal oxytocin in children with autism spectrum disorder.https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R0000... (first registered June 2015).

NCT00198120 {published data only}

1. NCT00198120. Safety and effectiveness of D-cycloserine in children with autism [A randomized controlled trial of D-cycloserine in autism].clinicaltrials.gov/ct2/show/NCT00198120 (first received 20 September 2005).

NCT01914939 {published data only}

1. NCT01914939. A randomized, controlled trial of intranasal oxytocin as an adjunct to behavioral therapy for autism spectrum disorder.clinicaltrials.gov/ct2/show/NCT01914939 (first received 2 August 2013).

NCT01970345 {published data only}

1. NCT01970345. A pilot treatment study of insulin-like growth factor-1 (IGF-1) in autism spectrum disorder.clinicaltrials.gov/ct2/show/NCT01970345 (first received 28 October 2013).

NCT03553875 {published data only}

1. NCT03553875. Memantine for the treatment of social deficits in youth with disorders of impaired social interactions [Memantine for the treatment of social deficits in youth with disorders of impaired social interactions: a randomized controlled trial].clinicaltrials.gov/show/NCT03553875 (first received 12 June 2018).

NCT03887676 {published data only}

1. NCT03887676. Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD.clinicaltrials.gov/ct2/show/NCT03887676?term=NCT03887676%draw=2&rank=1 (first received 18 March 2019).

NCT04520685 {published data only}

1. NCT04520685. CASCADE: CAnnabidiol Study in Children with Autism Spectrum DisordEr [CAnnabidiol Study in Children With Autism Spectrum DisordEr (CASCADE): a double-blind, placebo-controlled study to investigate efficacy and safety of cannabidiol in children and adolescents with autism].clinicaltrials.gov/ct2/show/NCT04520685 (first received 20 August 2020).

NCT04725383 {published data only}

1. NCT04725383. Amitriptyline for repetitive behaviors in autism spectrum disorders.www.clinicaltrails.gov/ct2/showNCT04725383?term=NCT04725383&draw=2&rank=1 (first received 1 July 2023).

NCT04745026 {published data only}

1. EUCTR2020-002819-21. An exploratory, Phase 2, randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of cannabidiol oral solution (GWP42003-P; CBD-OS) in children and adolescents with autism spectrum disorder.clinicaltrialregister.eu/ctr-search/trial/2020-002819-21/DE (first received April 2021).
1. NCT04745026. Trial to investigate the safety and efficacy of cannabidiol oral solution (GWP42003-P; CBD-OS) in children and adolescents with autism spectrum disorder.clinicaltrials.gov/ct2/show/NCT04745026?term=NCT04745026&draw=2&rank=1 (first received February 2021).

NCT04895215 {published data only}

1. NCT04895215. AB-2004 in Treatment of adolescents with irritability associated with autism spectrum sisorder (ASD). AB-2004 in Treatment of adolescents with irritability associated with autism spectrum disorder (ASD) - full text view -ClinicalTrials.gov (first received May 2021).

NCT05015439 {published data only}

1. NCT05015439. Cannabidiol (CBD) in adults With ASD. Cannabidiol (CBD) in adults With ASD - full text view -ClinicalTrials.gov (first received August 2021).

NCT05163717 {published data only}

1. NCT05163717. INP105 proof-of-concept study for the acute treatment of agitation in adolescents with ASD (CALM 201).www.clinicaltrials.gov/ct2/show/NCT05163717 (first received 20 December 2021).

NCT05182697 {published data only}

1. NCT05182697. SCI-210 in the treatment of children and young adults with autism evaluate the safety, tolerability and efficacy of SCI-210 in children with autism spectrum disorder (ASD). www.clinicaltrials.govct/show/NCT05182697?term=NCT05182697&draw=2&rank=1 (first received January 2022).

Parellada 2021 {published data only}

1. NCT03682978. Arbaclofen in children and adolescents with ASD (AIMS2-CT1).clinicaltrials.gov/ct2/show/NCT03682978?term=NCT03682978&draw=2&rank=1 (first received 25 March 2019).
1. Parellada M, Cáceres AS, Palmer M, Delorme R, Jones EJ, Parr JR, et al. A phase II randomised, double-blind, placebo-controlled study of the efficacy, safety and tolerability of arbaclofen administered for the treatment of social function in children and adolescents with autism spectrum disorders - study protocol for AIMS-2-TRIALS-CT1. Frontiers in Psychiatry 2021;12:701729. [DOI: 10.3389/fpsyt.2021.701729] - DOI - PMC - PubMed

UMIN000017876 {published data only}UMIN000017876

1. UMIN000017876. Effects of long-term administration of intranasal oxytocin in children with autism spectrum disorder.upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020712 (first received 19 June 2015).

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