Aripiprazole (Abilify) Now FDA-Approved to Decrease Irritability in Children with Autism

April 29, 2010 · Posted in Current Treatments 

In a recent study, children 6-12 years old with autism were treated with aripiprazole and showed improvement in irritability. The study lasted 52 weeks and had an open-label flexible-dose design (ranging from 2-15 mg/day) with an average dose of 9.6 mg/day. Few discontinuations occurred due to adverse effects, suggesting that aripiprazole is generally safe for use in this patient cohort.  Increase in weight gain was the reason seven subjects (2%) discontinued the drug, although weight gain appeared to plateau with continued treatment.

Aripiprazole is already FDA-approved for the treatment and prevention of mania in adults and children (10-17 years). It is also approved as an adjunct (add-on) to poorly effective antidepressants in adults with unipolar (non-psychotic) major depression.

EDITOR’S NOTE: The general safety and tolerability of aripiprazole for the treatment of irritability in children with autistic disorder in this study means the drug can be added to the list of potential treatments for patients with autism.  Previously, only risperidone had shown strong placebo-controlled data for efficacy in autism. A study by Hollander published in Neuropsychopharmacology this year indicated that valproate was also significantly better than placebo in treating irritability in children with autism spectrum disorders.

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