title: The efficacy and safety of lower doses of aripiprazole for the treatment of patients with acute exacerbation of schizophrenia.
abstract: BACKGROUND
  Efficacy and safety of aripiprazole administered at doses lower than those previously studied systematically were investigated in patients with acute exacerbation of schizophrenia.
  
  
  METHODS
  In this double-blind, multicenter study, 367 patients requiring inpatient hospitalization for acute relapse of schizophrenia were randomized to one of three fixed doses of aripiprazole (2, 5, or 10 mg/day) or placebo for 6 weeks. Efficacy and safety parameters were assessed weekly. Primary outcome measure was mean change from baseline in Positive and Negative Syndrome Scale (PANSS) Total score at endpoint.
  
  
  RESULTS
  Aripiprazole 10 mg/day produced statistically significantly greater improvements from baseline compared with placebo for PANSS Total at endpoint (-11.3 vs -5.3; P=.03) and at weeks 2-5. Aripiprazole 5 mg/day did not produce significantly greater improvement in PANSS Total compared with placebo at endpoint, although significant differences were seen at weeks 3-5. No statistically significant improvements compared with placebo were achieved with aripiprazole 2 mg/day at any time points. All aripiprazole doses were well tolerated. Aripiprazole was not associated with significant extrapyramidal symptoms.
  
  
  CONCLUSIONS
  While aripiprazole 5 mg/day warrants further study, the 10 mg/day dose provides effective and well-tolerated therapy for management of acute psychosis in patients with schizophrenia.
authors.affiliation: Department of Psychiatry, University of Florida, Gainesville, FL 32751, USA. acutler@coreresearch.com
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Cutler
authors.forename: Ronald N
authors.initials: RN
authors.lastname: Marcus
authors.forename: Sterling A
authors.initials: SA
authors.lastname: Hardy
authors.forename: Amy
authors.initials: A
authors.lastname: O'Donnell
authors.forename: William H
authors.initials: WH
authors.lastname: Carson
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
mesh_terms: D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000068180:Aripiprazole; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D015363:Quinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole