A Placebo-Controlled, Fixed-Dose Study of Aripiprazole in Children and Adolescents With Irritability Associated With Autistic Disorder

TLDR: Aripiprazole was efficacious and generally safe and well tolerated in the treatment of children and adolescents with irritability associated with autistic disorder.

Abstract: Objective To evaluate the short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Method Two hundred eighteen children and adolescents (aged 6–17 years) with a diagnosis of autistic disorder, and with behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these symptoms, were randomized 1:1:1:1 to aripiprazole (5, 10, or 15 mg/day) or placebo in this 8-week double-blind, randomized, placebo-controlled, parallel-group study. Efficacy was evaluated using the caregiver-rated Aberrant Behavior Checklist Irritability subscale (primary efficacy measure) and the clinician-rated Clinical Global Impressions–Improvement score. Safety and tolerability were also assessed. Results At week 8, all aripiprazole doses produced significantly greater improvement than placebo in mean Aberrant Behavior Checklist Irritability subscale scores (5 mg/day, −12.4; 10 mg/day, −13.2; 15 mg/day, −14.4; versus placebo, −8.4; all p p Conclusions Aripiprazole was efficacious and generally safe and well tolerated in the treatment of children and adol escents with irritability associated with autistic disorder. J. Am. Acad. Child Adolesc. Psychiatry , 2009;48(11):1110–1119.