Status:
COMPLETED
Study of Aripiprazole to Treat Children and Adolescents With Autism
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Autistic Disorder
Asperger Syndrome
Eligibility:
All Genders
30-17 years
Phase:
PHASE2
Brief Summary
The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and develo...
Detailed Description
The purpose of this open label study in children and adolescents with autism spectrum disorders (ASD) is to examine the acute (12 week) and long-term (1 year) effects of aripiprazole on problem behavi...
Eligibility Criteria
Inclusion
- Subjects must be between 30 months and 17 years 11 months, male or female, of any ethnicity and of any cognitive level
- Meet criteria for diagnosis of autism, Asperger's Disorder or Pervasive Developmental Order NOS (i.e. an autism spectrum disorder) based on clinical evaluation and either the Autism Diagnostic Interview - Revised (ADI-R) or the Autism Diagnostic Observation Scale (ADOS)
- Have a guardian who is able and willing to give written informed consent
- If competent, subject able and willing to give written assent for their own participation
- If on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant regimen for at least 6 months
- Subjects may receive other nonpharmacologic treatment including dietary treatments
Exclusion
- Diagnosis of Rett's syndrome or Child Disintegrative Disorder
- Taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks
- Previous trial of aripiprazole
- Pregnant or nursing
- Epilepsy or another significant chronic medical illness
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00619190
Start Date
January 1 2006
End Date
June 1 2012
Last Update
March 26 2014
Active Locations (1)
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1
University of North Carolina, Department of Psychiatry
Chapel Hill, North Carolina, United States, 27514