title: Aripiprazole for the treatment of pediatric bipolar I disorder: a 30-week, randomized, placebo-controlled study.
abstract: OBJECTIVE
  To evaluate the long-term efficacy, safety, and tolerability of aripiprazole in pediatric subjects with bipolar I disorder.
  
  
  METHODS
  A randomized, double-blind, 30-week, placebo-controlled study of aripiprazole (10 or 30 mg/day) in youths (10-17 years) with bipolar I disorder (manic or mixed) ± psychotic features (n = 296) was performed. After four weeks, acute treatment completers continued receiving ≤26 weeks of double-blind treatment (n = 210). The primary outcome was Young Mania Rating Scale (YMRS) total score change.
  
  
  RESULTS
  Of the 210 subjects who entered the 26-week extension phase, 32.4% completed the study (45.3% for aripiprazole 10 mg/day, 31.0% for aripiprazole 30 mg/day, and 18.8% for placebo). Both aripiprazole doses demonstrated significantly (p < 0.001) greater improvements in YMRS total score at endpoint compared with placebo in protocol-specified last observation carried forward analyses, but not in observed case or mixed-model repeated measures at week 30. Overall time to all-cause discontinuation was longer for aripiprazole 10 mg/day (15.6 weeks) and aripiprazole 30 mg/day (9.5 weeks) compared with placebo (5.3 weeks; both p < 0.05 versus placebo). Both aripiprazole doses were significantly superior to placebo regarding response rates, Children's Global Assessment of Functioning and Clinical Global Impressions-Bipolar severity of overall and mania scores at endpoint in all analyses. Commonly reported adverse events included headache, somnolence, and extrapyramidal disorder.
  
  
  CONCLUSIONS
  Aripiprazole 10 mg/day and 30 mg/day were superior to placebo and generally well tolerated in pediatric subjects with bipolar I disorder up to 30 weeks. Despite the benefits of treatment, completion rates were low in all treatment arms.
authors: Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine and The Kennedy Krieger Institute, Johns Hopkins University, Baltimore, MD, USA. RFindli1@jhmi.edu
authors: Robert L
authors: RL
authors: Findling
authors: Christoph U
authors: CU
authors: Correll
authors: Margaretta
authors: M
authors: Nyilas
authors: Robert A
authors: RA
authors: Forbes
authors: Robert D
authors: RD
authors: McQuade
authors: Na
authors: N
authors: Jin
authors: Svetlana
authors: S
authors: Ivanova
authors: Raymond
authors: R
authors: Mankoski
authors: William H
authors: WH
authors: Carson
authors: Gabrielle A
authors: GA
authors: Carlson
mesh_terms: D000293:Adolescent; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000188:drug therapy*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole