title: A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia.
abstract: OBJECTIVE
  Aripiprazole is a dopamine partial agonist approved for use in adults for short- and long-term treatment of schizophrenia and bipolar disorder. This study was designed to examine the acute efficacy, safety, and tolerability of aripiprazole for adolescents with schizophrenia.
  
  
  METHODS
  This was a 6-week multicenter, double-blind, randomized, placebo-controlled trial. Subjects 13 to 17 years old with a DSM-IV diagnosis of schizophrenia and a Positive and Negative Syndrome Scale (PANSS) total score of 70 or more were randomly assigned (1:1:1 ratio) to placebo or 10 or 30 mg/day of aripiprazole. The primary endpoint was mean change from baseline to endpoint (last observation carried forward) in PANSS total score. Assessments of safety and tolerability included spontaneously reported adverse events, extrapyramidal symptom scores, serum prolactin concentration, body weight, and metabolic measures.
  
  
  RESULTS
  Of 302 patients, 85% completed the 6-week study. The mean baseline PANSS score was 94.1. At the end of the study, both aripiprazole doses showed statistically significant differences from placebo in reduction in PANSS total score. Adverse events occurring in more than 5% of either aripiprazole group and with a combined incidence at least twice the rate for placebo were extrapyramidal disorder, somnolence, and tremor. Mean changes in prolactin were -8.45, -11.93, and -15.14 ng/ml for placebo and 10 mg and 30 mg of aripirazole, respectively. Mean body weight changes were -0.8, 0.0, and 0.2 kg for placebo and 10 mg and 30 mg of aripiprazole, respectively.
  
  
  CONCLUSIONS
  Both 10- and 30-mg/day doses of aripiprazole were superior to placebo in the acute treatment of adolescents with schizophrenia. Aripiprazole was generally well tolerated.
authors.affiliation: Department of Child and Adolescent Psychiatry, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH 44106-5080, USA. robert.findling@UHhospitals.org
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.forename: Adelaide
authors.initials: A
authors.lastname: Robb
authors.forename: Margaretta
authors.initials: M
authors.lastname: Nyilas
authors.forename: Robert A
authors.initials: RA
authors.lastname: Forbes
authors.forename: Na
authors.initials: N
authors.lastname: Jin
authors.forename: Svetlana
authors.initials: S
authors.lastname: Ivanova
authors.forename: Ronald
authors.initials: R
authors.lastname: Marcus
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.forename: Taro
authors.initials: T
authors.lastname: Iwamoto
authors.forename: William H
authors.initials: WH
authors.lastname: Carson