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

Randall Owen, Linmarie Sikich, Ronald N. Marcus, Patricia Corey-Lisle, George Manos, Robert D. McQuade, William H. Carson, Robert L. Findling

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1533-1540
Number of pages8
JournalPediatrics
Volume124
Issue number6
DOIs
StatePublished - Dec 1 2009
Externally publishedYes

Keywords

  • Aripiprazole
  • Autistic disorder
  • Pediatrics

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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    Owen, R., Sikich, L., Marcus, R. N., Corey-Lisle, P., Manos, G., McQuade, R. D., Carson, W. H., & Findling, R. L. (2009). Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Pediatrics, 124(6), 1533-1540. https://doi.org/10.1542/peds.2008-3782