期刊
INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY
卷 21, 期 1, 页码 1-9出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/01.yic.0000182118.57510.d1
关键词
Japan; major depressive disorder; sertraline
The objective of this double-blind, placebo-controlled, multicentre randomized withdrawal study was to evaluate the efficacy and tolerability of sertraline for 16 weeks in treating Japanese patients with major depressive disorder (MDD) who had achieved a response to 8 weeks of sertraline treatment. Patients (n = 361) were initially treated with 8 weeks of open-label sertraline treatment followed by 16 weeks of double-blind treatment with either sertraline (50-100 mg/day) or placebo. Responders during the open-label phase were eligible to be entered into the doubleblind phase. A total of 235 patients (65.1%) were entered to the double-blind phase and randomly assigned to receive sertraline (n = 117) or placebo (n = 118). A significantly (P= 0.016) lower relapse rate was found for sertraline (8.5%) compared to placebo (119.5%) during the doubleblind phase. Examination of time-to-relapse showed that the relapse free rate curve was significantly higher for sertraline (log-rank test, P = 0.026) than placebo. Mean changes from beginning to end of the double-blind phase on measure of depressive symptoms, quality of life and global improvement also significantly favoured sertraline over placebo. Sertraline was well-tolerated, with similar adverse events as found in previous studies. These results confirm the efficacy of sertraline in preventing the relapse of MDD in Japanese patients.
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