Status:
COMPLETED
An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Autism
Asperger's Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
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 Autism Spectrum Disorder (ASD) over a...
Detailed Description
Study Design: Fifteen patients with DSM-IV diagnoses of Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS) will be enrolled in this 12-week open-label st...
Eligibility Criteria
Inclusion
- Males and Females ages 6-17
- A diagnosis of Autism, Asperger's Disorder, or Pervasive Developmental Disorder - not otherwise specified (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
- Co-morbid serious mental illness.
- Intelligence Quotient (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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00308074
Start Date
February 1 2006
End Date
February 1 2009
Last Update
February 15 2017
Active Locations (1)
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1
Cambridge Health Alliance
Medford, Massachusetts, United States, 02155