title: Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study.
abstract: OBJECTIVE
  To report the long-term efficacy of aripiprazole in the treatment of irritability in children and adolescents (ages 6-17 years) with autistic disorder.
  
  
  METHODS
  This was a 52-week, open-label, flexible-dose (2-15 mg/day) study of aripiprazole for the treatment of children and adolescents with irritability associated with autistic disorder. Eligible subjects were enrolled from two 8-week randomized trials or were enrolled as de novo subjects. "Prior aripiprazole" subjects had received treatment with aripiprazole for 8 weeks before entering this study. Evaluation of efficacy, a secondary objective after evaluation of safety and tolerability in this study, was conducted using the caregiver-rated Aberrant Behavior Checklist-Irritability subscale and the clinician-rated Clinical Global Impression-Improvement score.
  
  
  RESULTS
  Three hundred thirty subjects received treatment (de novo, n = 86; prior aripiprazole, n = 174; prior placebo, n = 70) and 199 subjects (60.3%) completed 52 weeks of treatment. At their last study visit, 38.2% of subjects were receiving concomitant central nervous system medications (commonly antidepressants, 13.4%; psychostimulants, 11.5%; antiepileptics, 5.9%). At week 52 (observed cases data set), the mean change from baseline in Aberrant Behavior Checklist Irritability subscale scores was -8.0 in de novo subjects and -6.1 in prior placebo subjects; prior aripiprazole subjects maintained symptom improvement that was achieved with treatment in the prior study. At endpoint, the majority of subjects had a Clinical Global Impressions-Improvement score of 2 (much improved) or 1 (very much improved).
  
  
  CONCLUSIONS
  Aripiprazole reduced symptoms of irritability associated with autistic disorder in pediatric subjects ages 6-17 years who were studied for up to 1 year.
authors.affiliation: Bristol-Myers Squibb, Wallingford, Connecticut, USA.
authors.forename: Ronald N
authors.initials: RN
authors.lastname: Marcus
authors.forename: Randall
authors.initials: R
authors.lastname: Owen
authors.forename: George
authors.initials: G
authors.lastname: Manos
authors.forename: Raymond
authors.initials: R
authors.lastname: Mankoski
authors.forename: Lisa
authors.initials: L
authors.lastname: Kamen
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.forename: William H
authors.initials: WH
authors.lastname: Carson
authors.forename: Patricia K
authors.initials: PK
authors.lastname: Corey-Lisle
authors.forename: Michael G
authors.initials: MG
authors.lastname: Aman
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D001321:Autistic Disorder / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects*; D008297:Male; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole