Acute and Long-Term Treatment and Prevention of Relapse of Obsessive-Compulsive Disorder With Paroxetine
J Clin Psychiatry 2003;64(9):1113-1121
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Background: Limited information is
available regarding optimal dosing or long-term pharmacotherapy
with serotonin reuptake inhibitors in obsessive-compulsive
disorder. This study evaluated the acute safety and efficacy and
long-term efficacy, safety, and impact on relapse prevention of
paroxetine in obsessive-compulsive disorder.
Method: We enrolled 348 outpatients with
DSM-III-R obsessive-compulsive disorder in phase 1, a 12-week
randomized, double-blind, parallel study of fixed doses of
paroxetine (20 mg/day, 40 mg/day, or 60 mg/day) and placebo. In
phase 2, 263 phase 1 completers were enrolled in 6 months of
flexibly dosed open-label paroxetine treatment. In phase 3, 105
responders to open-label paroxetine were randomized to 6-month
double-blind, fixed-dose, parallel paroxetine/placebo treatment
to evaluate long-term efficacy, safety, and impact on relapse
prevention. The study was conducted from July 1991 to February
Results: Patients in phase 1 acute
treatment receiving 40 mg/day or 60 mg/day of paroxetine improved
significantly (p < .05) more than those receiving placebo; the
mean reduction in Yale-Brown Obsessive-Compulsive Scale score was
25% on 40 mg/day of paroxetine and 29% on 60 mg/day compared with
13% on placebo. During phase 3, long-term treatment, a greater
proportion of placebo- (59%) than paroxetine-treated (38%)
patients relapsed. Paroxetine was well tolerated at all doses,
with no significant increase in frequency of adverse events
during long-term compared with short-term therapy. Greater
adverse events in the placebo than in the paroxetine group in
phase 3 probably represent a discontinuation effect.
Conclusion: Paroxetine doses of 40 mg/day
and 60 mg/day (but not 20 mg/day) are effective in treating acute
obsessive-compulsive disorder. Long-term treatment with
paroxetine is effective and safe, decreases the rate of relapse,
and lengthens the time to relapse.