title: A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania.
abstract: OBJECTIVE
  The authors compared the efficacy and safety of aripiprazole, a novel antipsychotic, to placebo for treatment of patients in an acute manic or mixed episode of bipolar disorder.
  
  
  METHODS
  This 3-week, multicenter, double-blind study randomly assigned 262 bipolar disorder patients in an acute manic or mixed episode to aripiprazole, 30 mg/day (reduced to 15 mg/day if needed for tolerability), or placebo. Patients remained hospitalized for at least 2 of the weeks. The primary efficacy measure was mean change from baseline in total score on the Young Mania Rating Scale; response was defined as a decrease in score of > or =50%.
  
  
  RESULTS
  Aripiprazole produced statistically significant mean improvements in total score on the Young Mania Rating Scale compared with placebo (-8.2 versus -3.4, respectively) and produced a significantly higher response rate (40% versus 19%). For key efficacy variables (response per Young Mania Rating Scale; Clinical Global Impression-Bipolar Version scores for severity of illness [mania] and change from preceding phase [mania]), aripiprazole separated from placebo by day 4. The completion rate was significantly higher with aripiprazole than with placebo (42% versus 21%). Discontinuations due to adverse events did not differ significantly between the aripiprazole and placebo groups. There were no significant changes in body weight versus placebo, and aripiprazole was not associated with elevated serum prolactin or QTc prolongation.
  
  
  CONCLUSIONS
  Aripiprazole had significantly greater efficacy than placebo for the treatment of bipolar disorder patients in acute manic or mixed episodes and was safe and well tolerated in this randomized controlled trial.
authors.affiliation: Biological Psychiatry Program, Department of Psychiatry, University of Cincinnati College of Medicine, PO Box 670559, Cincinnati, OH 45267-0559, USA. paul.keck@uc.edu
authors.forename: Paul E
authors.initials: PE
authors.lastname: Keck
authors.forename: Ronald
authors.initials: R
authors.lastname: Marcus
authors.forename: Stavros
authors.initials: S
authors.lastname: Tourkodimitris
authors.forename: Mirza
authors.initials: M
authors.lastname: Ali
authors.forename: Amy
authors.initials: A
authors.lastname: Liebeskind
authors.forename: Anutosh
authors.initials: A
authors.lastname: Saha
authors.forename: Gary
authors.initials: G
authors.lastname: Ingenito
mesh_terms: D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D010919:Placebos; D015363:Quinolones; D000068180:Aripiprazole