title: A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole for the treatment of acute manic or mixed episodes in Asian patients with bipolar I disorder (the AMAZE study).
abstract: OBJECTIVE
  To investigate the efficacy and safety of aripiprazole in Asian patients with manic or mixed episodes associated with bipolar I disorder.
  
  
  METHODS
  Subjects were randomised to aripiprazole (24 mg/day; reduced to 12 mg/day if needed for tolerability; n = 128) or placebo (n = 130) for 3 weeks in this multicentre, double-blind study. The primary efficacy measure was mean change from baseline in Young Mania Rating Scale (YMRS) Total score.
  
  
  RESULTS
  A total of 136 patients (aripiprazole 56.3%; placebo 49.2%) completed the study. The majority of patients (92.6%) received aripiprazole 24 mg/day. Aripiprazole produced statistically significant mean improvements in YMRS Total scores compared with placebo from Day 4 through to Week 3 (-11.3 vs. -5.3; P < 0.001). The most common adverse events (> 15% of patients; aripiprazole vs. placebo) were akathisia (22.0 vs. 5.6%) and insomnia (16.3 vs. 9.6%). Aripiprazole treatment resulted in no significant difference from placebo in change in mean body weight from baseline (-0.4 vs. -0.7 kg; P = 0.231). Aripiprazole was not associated with an elevated serum prolactin level.
  
  
  CONCLUSIONS
  Aripiprazole had significantly greater efficacy than placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder in Asian patients. Treatment was generally safe and well tolerated.
authors.affiliation: Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University , Fukuoka , Japan.
authors.forename: Shigenobu
authors.initials: S
authors.lastname: Kanba
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Kawasaki
authors.forename: Jun
authors.initials: J
authors.lastname: Ishigooka
authors.forename: Kaoru
authors.initials: K
authors.lastname: Sakamoto
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Toshihide
authors.initials: T
authors.lastname: Kuroki
mesh_terms: D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000068180:Aripiprazole; D001208:Asia; D044466:Asian People; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D010919:Placebos; D015363:Quinolones; D000068180:Aripiprazole