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An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

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


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00308074

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

Responsible Party: Jean Frazier, MD, Cambridge Health Alliance 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

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Developmental Disabilities
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on December 09, 2016