Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study.

Abstract

AIM:

To report the long-term efficacy of aripiprazole in the treatment of irritability in children and adolescents (ages 6-17 years) with autistic disorder.

METHODS:

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.

RESULTS:

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).

CONCLUSION:

Aripiprazole reduced symptoms of irritability associated with autistic disorder in pediatric subjects ages 6-17 years who were studied for up to 1 year.

• Authors: Ronald N Marcus, Randall Owen, George Manos, Raymond Mankoski, Lisa Kamen, Robert D McQuade, William H Carson, Patricia K Corey-Lisle, Michael G Aman
• Journal: Journal of child and adolescent psychopharmacology (J Child Adolesc Psychopharmacol) Vol. 21 Issue 3 Pg. 229-36 (Jun 2011) ISSN: 1557-8992 [Electronic] United States
• PMID: 21663425 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antipsychotic Agents
• Piperazines
• Quinolones
• Aripiprazole

Topics

• Adolescent
• Antipsychotic Agents (adverse effects, therapeutic use)
• Aripiprazole
• Autistic Disorder (drug therapy, psychology)
• Child
• Female
• Follow-Up Studies
• Humans
• Irritable Mood (drug effects)
• Male
• Piperazines (adverse effects, therapeutic use)
• Psychiatric Status Rating Scales
• Quinolones (adverse effects, therapeutic use)
• Treatment Outcome