Aripiprazole: in the treatment of irritability associated with autistic disorder in pediatric patients.

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 2-15 mg/day, compared with placebo, resulted in significant improvements in the Aberrant Behavior Checklist Irritability subscale 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.