Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2005;7(2):53-60.
doi: 10.4088/pcc.v07n0203.

Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: Remission Analysis Following a Randomized, Double-Blind, Placebo-Controlled Trial

Affiliations

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.

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.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Study Design
Figure 2.
Figure 2.
Study Flow
Figure 3.
Figure 3.
Mean VAS-Total Score by Cyclea

Similar articles

Cited by

References

    1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Washington, DC: American Psychiatric Association. 1994
    1. 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
    1. Rivera-Tovar AD, Frank E.. Late luteal phase dysphoric disorder in young women. Am J Psychiatry. 1990;147:1634–1636. - PubMed
    1. 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
    1. 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