Status:
COMPLETED
Aripiprazole in Children With Autism: A Pilot Study
Lead Sponsor:
Drexel University College of Medicine
Conditions:
Autism
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief Summary
This is a 6-week open pilot study of aripiprazole for the treatment of adolescents, aged 12 to 18 years, diagnosed with autism. Children who qualify for the study will be treated with aripiprazole fo...
Detailed Description
I. SPECIFIC AIM To obtain pilot data regarding the safety, dosing, and efficacy of open-labeled aripiprazole in children, aged 12 to 18 years, diagnosed with autism. A larger, more controlled trial w...
Eligibility Criteria
Inclusion
- Diagnosis of autism (DSM-IV) made by a boarded child and adolescent psychiatrist.
- Males and females.
- Aged 12 to 18 years.
- Clinical judgment that medication treatment for autism is indicated.
Exclusion
- Major medical problems including cardiac, liver, endocrine, or renal diseases.
- Uncontrolled seizures.
- Baseline QTC greater than 425 msec.
- Concomitant treatment with psychotropic medication.
- History of prior exposure to aripiprazole.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00208533
Start Date
February 1 2004
End Date
November 16 2011
Last Update
July 30 2018
Active Locations (1)
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1
Drexel University College of Medicine at Friends Hospital
Philadelphia, Pennsylvania, United States, 19124