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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00198055
First received: September 12, 2005
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Asperger's Disorder
Pervasive Developmental Disorder
 Drug: aripiprazole
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of Aripiprazole in Children and Adolescents With Autistic Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • The Clinical Global Impression(CGI)Improvement Scale. [ Time Frame: Every 2 Weeks ] [ Designated as safety issue: No ]
  • The Irritability subscale of the Aberrant Behavior Checklist (ABC) [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Clinical Global Impression Severity Scale. [ Time Frame: At baseline and endpoint ] [ Designated as safety issue: No ]
  • The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS). [ Time Frame: At baseline and endpoint ] [ Designated as safety issue: No ]
  • The Vineland Maladaptive Behavior Subscale. [ Time Frame: At baseline and endpoint ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Drug: 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.
Other Name: Abilify

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.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198055

Locations
United States, Indiana
Riley Hospital, Riley Child and Adolescent Psychiatry Clinic
Indianapolis, Indiana, United States, 46020
Sponsors and Collaborators
Indiana University School of Medicine
Bristol-Myers Squibb
Investigators
Principal Investigator: Kimberly A. Stigler, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00198055     History of Changes
Other Study ID Numbers: 0302-24
Study First Received: September 12, 2005
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Aggression
Behavioral symptoms

Additional relevant MeSH terms:
Developmental Disabilities
Asperger Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Aripiprazole
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013