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Aripiprazole

In the Treatment of Irritability Associated with Autistic Disorder in Pediatric Patients

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Abstract

Aripiprazole is an atypical antipsychotic approved for the treatment of irritability associated with autistic disorder in pediatric patients aged 6–17 years.

In two, randomized, double-blind, placebo-controlled studies in pediatric patients aged 6–17 years with irritability associated with autistic disorder, 8 weeks of treatment with aripiprazole 2–15mg/day, compared with placebo, resulted in significant improvements in the Aberrant Behavior Checklist Irritability sub-scale score at endpoint (primary endpoint), and the mean Clinical Global Impression-Improvement score.

Aripiprazole was generally well tolerated in this patient population in the two 8-week studies and a 52-week study, with most adverse events being mild to moderate in severity. Aripiprazole was associated with weight gain in both the short- and long-term studies; data from the long-term study indicated that the increase in bodyweight reached a plateau at 3–6 months.

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Acknowledgments and Disclosures

This manuscript was reviewed by: C. Farmer, Ohio State University, Department of Psychology, Columbus, Ohio, USA; G.L. Holmes, Dartmouth Medical School, Department of Neurology, Lebanon, New Hampshire, USA; R.E. Kauffman, Children’s Mercy Hospital, Division of Clinical Pharmacology/Toxicology, Kansas City, Missouri, USA; J.M. Stachnik, College of Pharmacy, Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois, USA.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment of the article. Changes based on any comments received were made on the basis of scientific and editorial merit.

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    Monique P. Curran

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Correspondence to Monique P. Curran.

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Curran, M.P. Aripiprazole. Pediatr-Drugs 13, 197–204 (2011). https://doi.org/10.2165/11207230-000000000-00000

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