A Study of Aripiprazole in Children and Adolescents With Aspergers and Pervasive Developmental Disorder.

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This is an open-label investigation of aripiprazole in the management of the maladaptive behaviors of autistic disorder. We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Collaborator: Bristol-Myers Squibb
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Mental age of 18 months

• Diagnosis of Asperger's Disorder or Pervasive Developmental Disorder

• Good health overall

• Free of all psychotropic medication for 2 weeks

Exclusion Criteria:

• Weight less than 15kg

• Subjects who have received an adequate trial of aripiprazole

• An active seizure disorder

• A significant medical condition

• History of neuroleptic malignant syndrome

• Females with positive Beta human chorionic gonadotropin(HCG) pregnancy test