An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT00308074
First received: March 28, 2006
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from ASD over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Open-Label Trial of Aripiprazole Monotherapy in the Autism Spectrum Disorders (ASD)

Resource links provided by NLM:


Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • Clinical Global Impressions-Improvement [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist-Irritability subscale [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: February 2006
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Aripiprazole
    open-label, flexible-dosing
    Other Name: Abilify
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females ages 6-17
  • A diagnosis of Autism, Asperger's Disorder, or PDD NOS
  • Medically healthy
  • Ability to give assent
  • Significant tantrums, aggression, self-injurious behavior and/or agitation by achieving a score of 18 or higher on the Aberrant Behavior Checklist-irritability subscale and a score of moderate or higher on the Clinical Global Impressions-Severity Scale.

Exclusion Criteria:

  • Co-morbid serious mental illness.
  • IQ <50, based on verified records of cognitive testing performed within 2 years of enrollment. In event that suitable records of prior testing are unavailable, IQ will be estimated using the Wechsler Abbreviated Scale of Intelligence (WASI, 1999 Harcourt Assessment, Inc.).
  • Significant active medical and/or neurological illness.
  • Subjects that require other psychotropic medications such as antidepressants, mood stabilizers, anticonvulsants, stimulants, sedatives, or other antipsychotic medications in order to maintain clinical stability.
  • Active substance abuse/dependence based upon history and urine toxicology screen.
  • Inability to have blood drawn at baseline and termination visits.
  • Known allergy or hypersensitivity to aripiprazole or its ingredients.
  • Patients clinically stable on current medications.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308074

Locations
United States, Massachusetts
Cambridge Health Alliance
Medford, Massachusetts, United States, 02155
Sponsors and Collaborators
Cambridge Health Alliance
Bristol-Myers Squibb
Investigators
Principal Investigator: Jean A Frazier, MD Cambridge Health Alliance
  More Information

Additional Information:
No publications provided

Responsible Party: Jean Frazier, MD, Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00308074     History of Changes
Other Study ID Numbers: CHA-IRB-0119/06/05
Study First Received: March 28, 2006
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cambridge Health Alliance:
behavioral problems
aggression
autism
aripiprazole

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

ClinicalTrials.gov processed this record on October 29, 2014