Status:
COMPLETED
A Study of Aripiprazole in Children and Adolescents With Aspergers and Pervasive Developmental Disorder.
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Asperger's Disorder
Pervasive Developmental Disorder
Eligibility:
All Genders
4-17 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This is an open-lab...
Detailed Description
Pervasive developmental disorders (PDD) are characterized be severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research suggest...
Eligibility Criteria
Inclusion
- Mental age of 18 months
- Diagnosis of Asperger's Disorder or Pervasive Developmental Disorder
- Good health overall
- Free of all psychotropic medication for 2 weeks
Exclusion
- Weight less than 15kg
- Subjects who have received an adequate trial of aripiprazole
- An active seizure disorder
- A significant medical condition
- History of neuroleptic malignant syndrome
- Females with positive Beta human chorionic gonadotropin(HCG) pregnancy test
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00198055
Start Date
January 1 2005
End Date
September 1 2007
Last Update
June 4 2014
Active Locations (1)
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1
Riley Hospital, Riley Child and Adolescent Psychiatry Clinic
Indianapolis, Indiana, United States, 46020