doi: 10.4088/pcc.v07n0203.
Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: Remission Analysis Following a Randomized, Double-Blind, Placebo-Controlled Trial
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- PMID:15841196
- PMCID: PMC1079696
- DOI: 10.4088/pcc.v07n0203
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Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: Remission Analysis Following a Randomized, Double-Blind, Placebo-Controlled Trial
Teri B Pearlstein et al. Prim Care Companion J Clin Psychiatry.2005.
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Abstract
Objective: To compare the efficacy and safety of paroxetine controlled release (CR) (12.5 mg/day or 25 mg/day) versus placebo in premenstrual dysphoric disorder (PMDD).Method: A double-blind, randomized, placebo-controlled trial was conducted over 3 menstrual cycles in women aged 18-45 years with confirmed DSM-IV PMDD in 47 outpatient centers across the United States and Canada from November 1999 to January 2002. The primary efficacy measure was the visual analog scale (VAS)-Mood, which is the mean of 4 core symptoms: irritability, tension, depressed mood, and affective lability.Results: A statistically significant difference was observed in favor of paroxetine CR 25 mg versus placebo on the VAS-Mood (adjusted mean difference = -12.58 mm, 95% CI = -18.40 to -6.76; p < .001) and for paroxetine CR 12.5 mg versus placebo (adjusted mean difference = -7.51 mm, 95% CI = -13.40 to -1.62; p = .013). Paroxetine CR was generally well tolerated.Conclusion: Paroxetine CR doses of 12.5 mg/day and 25 mg/day are effective in treating PMDD and are well tolerated.
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Mean VAS-Total Score by Cyclea
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References
- American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Washington, DC: American Psychiatric Association. 1994
- Johnson SR, McChesney C, Bean JA.. Epidemiology of premenstrual symptoms in a non-clinical sample, 1: prevalence, natural history and help-seeking behavior. J Reprod Med. 1988;33:340–346. - PubMed
- Rivera-Tovar AD, Frank E.. Late luteal phase dysphoric disorder in young women. Am J Psychiatry. 1990;147:1634–1636. - PubMed
- Wittchen HU, Becker E, and Lieb R. et al. Prevalence, incidence and stability of premenstrual dysphoric disorder in the community. Psychol Med. 2002 32:119–132. - PubMed
- Sternfeld B, Swindle R, and Chawla A. et al. Severity of premenstrual symptoms in a health maintenance organization population. Obstet Gynecol. 2002 99:1014–1024. - PubMed
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