Teri B. Pearlstein, MD; Kevin M. Bellew, MS; Jean Endicott, PhD; Meir Steiner, PhD
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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.
Prim Care Companion J Clin Psychiatry 2005;7(2):53-60
https://doi.org/10.4088/PCC.v07n0203
© Copyright 2005 Physicians Postgraduate Press, Inc.