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

Phase 2

Completed

• Conditions: Pervasive Developmental Disorder; Asperger's Disorder
• Interventions: Drug: aripiprazole

• Registration Number: NCT00198055
• Lead Sponsor: Indiana University School of Medicine

Brief 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.

Detailed Description

Pervasive developmental disorders (PDD) are characterized be severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research suggests that a dysregulation of the dopamine and serotonin systems contributes to these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics were reported in subjects with PDD's, research shifted to the atypical antipsychotics, which have been shown to be better tolerated and effective in this population. However, the atypical antipsychotics have also been associated with adverse effects. Thus there remains a need for a novel pharmacotherapy that would be safe and effective for children and adolescents with PDD's including Asperger's disorder and PDD Not Otherwise Specified (PDD NOS). We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior. We also hypothesize that aripiprazole will be well tolerated, with low risk for extrapyramidal symptoms, hyperprolactinemia, weight gain, or corrected QT interval (QTc) prolongation. In addition, this open-label study will serve to stimulate more definitive, controlled research.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aripiprazole	aripiprazole	Aripiprazole 5 mg per day for 2 weeks, then can be increased to 10mg per day if tolerated for 2 weeks, then can be increased to 15 mg per day for 4 weeks.

Primary Outcome Measures

Name	Time	Method
The Irritability subscale of the Aberrant Behavior Checklist (ABC)	Every 2 weeks
The Clinical Global Impression(CGI)Improvement Scale.	Every 2 Weeks

Secondary Outcome Measures

Name	Time	Method
The Vineland Maladaptive Behavior Subscale.	At baseline and endpoint
The Clinical Global Impression Severity Scale.	At baseline and endpoint
The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS).	At baseline and endpoint

Trial Locations

Locations (1)

Riley Hospital, Riley Child and Adolescent Psychiatry Clinic; 🇺🇸 Indianapolis, Indiana, United States