Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder

Pediatrics. 2009 Dec;124(6):1533-40. doi: 10.1542/peds.2008-3782.


Objective: The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these.

Methods: This 8-week, double-blind, randomized, placebo-controlled, parallel-group study was conducted of children and adolescents (aged 6-17 years) with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression-Improvement score (CGI-I). Safety and tolerability were also assessed.

Results: Ninety-eight patients were randomly assigned to receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8. Aripiprazole demonstrated significantly greater global improvements than placebo, as assessed by the mean CGI-I score from week 1 through week 8; however, clinically significant residual symptoms may still persist for some patients. Discontinuation rates as a result of adverse events (AEs) were 10.6% for aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8.

Conclusions: Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated.

Trial registration: NCT00332241.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Antipsychotic Agents / adverse effects
  • Antipsychotic Agents / therapeutic use*
  • Aripiprazole
  • Autistic Disorder / diagnosis
  • Autistic Disorder / drug therapy*
  • Autistic Disorder / psychology
  • Child
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Irritable Mood / drug effects*
  • Male
  • Personality Assessment
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Quinolones / adverse effects
  • Quinolones / therapeutic use*
  • Treatment Outcome
  • Weight Gain / drug effects


  • Antipsychotic Agents
  • Piperazines
  • Quinolones
  • Aripiprazole

Associated data