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- Title
Aripiprazole plus divalproex for recently manic or mixed patients with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind maintenance trial.
- Authors
Woo, Young Sup; Bahk, Won-Myong; Chung, Moon Yong; Kim, Do-Hoon; Yoon, Bo-Hyun; Lee, Jong Hun; Ahn, Yong Min; Chung, Sang-Keun; Kim, Jeong-Gee; Lee, Kwang Heun; Paik, Ki-Chung
- Abstract
Objectives The goal of this study was to investigate the safety and efficacy in preventing relapse of a mood episode in recently manic or mixed episode patients with bipolar I disorder stabilized with aripiprazole and divalproex combination. Methods This randomized, 24-week, double-blind, placebo-controlled multicenter study enrolled patients from 23 centers in Korea. Patients with bipolar I disorder who had manic or mixed episode entered a 6-week open-label stabilization phase. After meeting stabilization criteria, 83 patients were randomly assigned to placebo + divalproex or aripiprazole + divalproex treatment group for the 24-week, double-blind maintenance phase. Results During the 6-month double-blind treatment, the time to relapse of any mood episode in the aripiprazole group was longer than the placebo group, but the difference did not reach statistical significance ( p = 0.098). After controlling for mean divalproex level, the time to depressive episode relapse in the aripiprazole group was longer than those in the placebo group ( p = 0.029). Weight gain (≥7% increase) occurred in 22.5% aripiprazole group and 18.6% placebo group ( p = 0.787). Conclusions In this study, relapse of mood episode occurred fewer and later for aripiprazole with divalproex treatment than divalproex monotherapy, but the differences were not statistically significant. Copyright © 2011 John Wiley & Sons, Ltd.
- Subjects
ARIPIPRAZOLE; BIPOLAR disorder; ANTIPSYCHOTIC agents; MENTAL illness treatment; PSYCHOPHARMACOLOGY
- Publication
Human Psychopharmacology: Clinical & Experimental, 2011, Vol 26, Issue 8, p543
- ISSN
0885-6222
- Publication type
Article
- DOI
10.1002/hup.1240