Aripiprazole plus divalproex for recently manic or mixed patients with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind maintenance trial
Article first published online: 2 DEC 2011
Copyright © 2011 John Wiley & Sons, Ltd.
Human Psychopharmacology: Clinical and Experimental
Volume 26, Issue 8, pages 543–553, December 2011
How to Cite
Woo, Y. S., Bahk, W.-M., Chung, M. Y., Kim, D.-H., Yoon, B.-H., Lee, J. H., Ahn, Y. M., Chung, S.-K., Kim, J.-G., Lee, K. H. and Paik, K.-C. (2011), Aripiprazole plus divalproex for recently manic or mixed patients with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind maintenance trial. Hum. Psychopharmacol. Clin. Exp., 26: 543–553. doi: 10.1002/hup.1240
- Issue published online: 13 DEC 2011
- Article first published online: 2 DEC 2011
- Manuscript Accepted: 30 SEP 2011
- Manuscript Received: 29 JUN 2011
- bipolar disorder;
- relapse prevention
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.
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.
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).
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.