title: Aripiprazole plus divalproex for recently manic or mixed patients with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind maintenance trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
authors.forename: Young Sup
authors.initials: YS
authors.lastname: Woo
authors.forename: Won-Myong
authors.initials: WM
authors.lastname: Bahk
authors.forename: Moon Yong
authors.initials: MY
authors.lastname: Chung
authors.forename: Do-Hoon
authors.initials: DH
authors.lastname: Kim
authors.forename: Bo-Hyun
authors.initials: BH
authors.lastname: Yoon
authors.forename: Jong Hun
authors.initials: JH
authors.lastname: Lee
authors.forename: Yong Min
authors.initials: YM
authors.lastname: Ahn
authors.forename: Sang-Keun
authors.initials: SK
authors.lastname: Chung
authors.forename: Jeong-Gee
authors.initials: JG
authors.lastname: Kim
authors.forename: Kwang Heun
authors.initials: KH
authors.lastname: Lee
authors.forename: Ki-Chung
authors.initials: KC
authors.lastname: Paik
mesh_terms: D000328:Adult; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage*; D015363:Quinolones / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage*
chemical_list: D010879:Piperazines; D015363:Quinolones; D014635:Valproic Acid; D000068180:Aripiprazole