We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00198055
First Posted: September 20, 2005
Last Update Posted: June 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Indiana University ( Indiana University School of Medicine ):

Primary Outcome Measures:
  • The Clinical Global Impression(CGI)Improvement Scale. [ Time Frame: Every 2 Weeks ]
  • The Irritability subscale of the Aberrant Behavior Checklist (ABC) [ Time Frame: Every 2 weeks ]

Secondary Outcome Measures:
  • The Clinical Global Impression Severity Scale. [ Time Frame: At baseline and endpoint ]
  • The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS). [ Time Frame: At baseline and endpoint ]
  • The Vineland Maladaptive Behavior Subscale. [ Time Frame: At baseline and endpoint ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00198055     History of Changes
Other Study ID Numbers: 0302-24
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: June 4, 2014
Last Verified: June 2014

Keywords provided by Indiana University ( Indiana University School of Medicine ):
Aggression
Behavioral symptoms

Additional relevant MeSH terms:
Disease
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Autistic Disorder
Neurodevelopmental Disorders
Mental Disorders
Asperger Syndrome
Pathologic Processes
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs