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

NCT00198055 | Completed Phase 2 DMC

• 1 other identifier: 0302-24
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Asperger's Disorder; Pervasive Developmental Disorder

Keywords

Aggression; Behavioral symptoms

Outcome Measures

Primary Outcomes (2)

• The Clinical Global Impression(CGI)Improvement Scale.

  Every 2 Weeks

• The Irritability subscale of the Aberrant Behavior Checklist (ABC)

  Every 2 weeks

Secondary Outcomes (3)

• 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

• The Vineland Maladaptive Behavior Subscale.

  At baseline and endpoint

Study Arms (1)

Aripiprazole

EXPERIMENTAL

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.

Drug: aripiprazole

Interventions

aripiprazole DRUG

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.

Also known as: Abilify

Aripiprazole

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Riley Hospital, Riley Child and Adolescent Psychiatry Clinic

Indianapolis, Indiana, 46020, United States

Location

MeSH Terms

Conditions

Asperger Syndrome; Child Development Disorders, Pervasive; Aggression; Behavioral Symptoms

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kimberly A. Stigler, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (1)