Aripiprazole plus divalproex for recently manic or mixed patients with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind maintenance trial

Authors


W-M. Bahk, Department of Psychiatry, College of Medicine, The Catholic University of Korea, #62 Yeouido-Dong, Youngdeungpo-Gu, Seoul, 150-713, South Korea. Tel: (82)-2-3779-1250; Fax: (82)-2-780-6577. E-mail: wmbahk@catholic.ac.kr

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.

Ancillary