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Published online November 30, 2009
PEDIATRICS Vol. 124 No. 6 December 2009, pp. 1533-1540 (doi:10.1542/peds.2008-3782)
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ARTICLE

Aripiprazole in the Treatment of Irritability in Children and Adolescents With Autistic Disorder

Randall Owen, MDa, Linmarie Sikich, MDb, Ronald N. Marcus, MDa, Patricia Corey-Lisle, PhDa, George Manos, PhDa, Robert D. McQuade, PhDc, William H. Carson, MDc, Robert L. Findling, MDd

a Bristol-Myers Squibb, Wallingford, Connecticut
b School of Medicine, University of North Carolina, Chapel Hill, North Carolina
c Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, New Jersey
d University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, Ohio

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.

Key Words: aripiprazole • autistic disorder • pediatrics

Abbreviations: EPS—extrapyramidal symptom • ADI-R—Autism Diagnostic Interview–Revised • CGI-S—Clinical Global Impression–Severity • ABC—Aberrant Behavior Checklist • ECG—electrocardiogram • CGI-I—Clinical Global Impression–Improvement • PedsQL—Pediatric Quality of Life Inventory • CGSQ—Caregiver Strain Questionnaire • AE—adverse event • ANCOVA—analysis of covariance • LOCF—last observation carried forward • TD—treatment difference • df—degrees of freedom • CI—confidence interval

Accepted Jul 9, 2009.


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