Aripiprazole in pervasive developmental disorder not otherwise specified and Asperger's disorder: a 14-week, prospective, open-label study.

Abstract

OBJECTIVE:

The aim of this study was to determine the effectiveness and tolerability of aripiprazole for irritability in pervasive developmental disorder not otherwise specified (PDD-NOS) and Asperger's disorder.

METHOD:

This is a 14-week, prospective, open-label investigation of aripiprazole in 25 children and adolescents diagnosed with PDD-NOS or Asperger's disorder. Primary outcome measures included the Clinical Global Impressions-Improvement (CGI-I) scale and the Irritability subscale of the Aberrant Behavior Checklist (ABC-I).

RESULTS:

Twenty-five subjects, ages 5-17 years (mean 8.6 years) received a mean final aripiprazole dosage of 7.8 mg/day (range 2.5-15 mg/day). Full-scale intelligence quotient (IQ) scores ranged from 48 to 122 (mean 84). Twenty-two (88%) of 25 subjects were responders in regard to interfering symptoms of irritability, including aggression, self-injury, and tantrums, with a final CGI-I of 1 or 2 (very much or much improved) and a 25% or greater improvement on the ABC-I. The final mean CGI-I was 1.6 (p <or= 0.0001). ABC-I scores ranged from 18 to 43 (mean 29) at baseline, whereas scores at week 14 ranged from 0 to 27 (mean 8.1) (p <or= 0.001). Aripiprazole was well tolerated. Mild extrapyramidal symptoms (EPS) were reported in 9 subjects. Age- and sex-normed body mass index (BMI) increased from a mean value of 20.3 at baseline to 21.1 at end point (p <or= 0.04). Prolactin significantly decreased from a mean value of 9.3 at baseline to 2.9 at end point (p <or= 0.0001). No subject exited the study due to a drug-related adverse event.

CONCLUSIONS:

These preliminary data suggest that aripiprazole may be effective and well tolerated for severe irritability in pediatric patients with PDD-NOS or Asperger's disorder. Larger-scale placebo-controlled studies are needed to elucidate the efficacy and tolerability of aripiprazole in this understudied population.

• Authors: Kimberly A Stigler, Jonathan T Diener, Arlene E Kohn, Lang Li, Craig A Erickson, David J Posey, Christopher J McDougle
• Journal: Journal of child and adolescent psychopharmacology (J Child Adolesc Psychopharmacol) Vol. 19 Issue 3 Pg. 265-74 (Jun 2009) ISSN: 1557-8992 [Electronic] United States
• PMID: 19519261 (Publication Type: Clinical Trial, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antipsychotic Agents
• Piperazines
• Quinolones
• Aripiprazole
• Prolactin

Topics

• Adolescent
• Antipsychotic Agents (adverse effects, therapeutic use)
• Aripiprazole
• Asperger Syndrome (drug therapy, physiopathology)
• Body Mass Index
• Child
• Child Development Disorders, Pervasive (drug therapy, physiopathology)
• Child, Preschool
• Female
• Humans
• Irritable Mood (drug effects)
• Male
• Pilot Projects
• Piperazines (adverse effects, therapeutic use)
• Prolactin (drug effects, metabolism)
• Prospective Studies
• Psychiatric Status Rating Scales
• Psychometrics
• Quinolones (adverse effects, therapeutic use)
• Severity of Illness Index