Status:
COMPLETED
Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Conditions:
Autism
Eligibility:
All Genders
5-17 years
Phase:
NA
Brief Summary
Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritabilit...
Detailed Description
Aripiprazole is an atypical antipsychotic medication which is currently approved for the treatment of schizophrenia in adults. Multiple clinical trials in both children and adults have shown the effec...
Eligibility Criteria
Inclusion
- Meets DSM-IV, ADI-R criteria for autistic disorder.
- Age 5-17 years.
- Outpatients
- Parent or legal guardian willing to sign informed consent.
Exclusion
- Subject has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
- Subject has caused visible harm to him/herself.
- Subject has an active seizure disorder or epilepsy (seizures within the past year).
- Subject has an unstable medical illness, including heart disease.
- Subject has experienced brain injury.
- Subject has a history of diabetes.
- Subject reports significant improvement of autism symptoms and behaviors to current medication or other therapies.
- Subject has a history of prior treatment with Aripiprazole of 5 mg/day or higher for 6 weeks.
- Subject lives in a far away area and/or does not have regular access to transportation to the clinical facility.
- Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00468130
Start Date
May 1 2006
End Date
November 1 2009
Last Update
January 14 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Child and Adolescent Psychiatry, University Behavioral Health Care Building
Piscataway, New Jersey, United States, 08854