Aripiprazole in the Treatment of Irritability in Pediatric Patients (Aged 6–17 Years) with Autistic Disorder: Results from a 52-Week, Open-Label Study

• Published in: Journal of child and adolescent psychopharmacology Vol. 21; no. 3; pp. 229 - 236
• Main Authors: Marcus, Ronald N., Owen, Randall, Manos, George, Mankoski, Raymond, Kamen, Lisa, McQuade, Robert D., Carson, William H., Corey-Lisle, Patricia K., Aman, Michael G.
• Format: Journal Article
• Language: English
• Published: United States Mary Ann Liebert, Inc 01.06.2011
• Subjects: Adolescent; Antipsychotic Agents - adverse effects; Antipsychotic Agents - therapeutic use; Aripiprazole; Autism; Autistic Disorder - drug therapy; Autistic Disorder - psychology; Child; Children & youth; Clinical trials; Complications and side effects; Dosage and administration; Drug therapy; Female; Follow-Up Studies; Humans; Irritable Mood - drug effects; Male; Patient outcomes; Piperazines - adverse effects; Piperazines - therapeutic use; Psychiatric Status Rating Scales; Psychotropic drugs; Quinolones - adverse effects; Quinolones - therapeutic use; Treatment Outcome; United States
• ISSN: 1044-5463; 1557-8992; 1557-8992
• DOI: 10.1089/cap.2009.0121

To report the long-term efficacy of aripiprazole in the treatment of irritability in children and adolescents (ages 6-17 years) with autistic disorder. This was a 52-week, open-label, flexible-dose (2-15 mg/day) study of aripiprazole for the treatment of children and adolescents with irritability associated with autistic disorder. Eligible subjects were enrolled from two 8-week randomized trials or were enrolled as de novo subjects. "Prior aripiprazole" subjects had received treatment with aripiprazole for 8 weeks before entering this study. Evaluation of efficacy, a secondary objective after evaluation of safety and tolerability in this study, was conducted using the caregiver-rated Aberrant Behavior Checklist-Irritability subscale and the clinician-rated Clinical Global Impression-Improvement score. Three hundred thirty subjects received treatment (de novo, n = 86; prior aripiprazole, n = 174; prior placebo, n = 70) and 199 subjects (60.3%) completed 52 weeks of treatment. At their last study visit, 38.2% of subjects were receiving concomitant central nervous system medications (commonly antidepressants, 13.4%; psychostimulants, 11.5%; antiepileptics, 5.9%). At week 52 (observed cases data set), the mean change from baseline in Aberrant Behavior Checklist Irritability subscale scores was -8.0 in de novo subjects and -6.1 in prior placebo subjects; prior aripiprazole subjects maintained symptom improvement that was achieved with treatment in the prior study. At endpoint, the majority of subjects had a Clinical Global Impressions-Improvement score of 2 (much improved) or 1 (very much improved). Aripiprazole reduced symptoms of irritability associated with autistic disorder in pediatric subjects ages 6-17 years who were studied for up to 1 year.