Status:
COMPLETED
Aripiprazole in Children and Adolescents With Bipolar I Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic fea...
Eligibility Criteria
Inclusion
- Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features
Exclusion
- Patients with certain other psychological disorders
- Patients with a co-morbid serious, uncontrolled systemic illness
- Patients with significant risk of committing suicide
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT00110461
Start Date
March 1 2005
End Date
February 1 2007
Last Update
May 21 2012
Active Locations (53)
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1
Local Institution
Scottsdale, Arizona, United States
2
Local Institution
Little Rock, Arkansas, United States
3
Local Institution
National City, California, United States
4
Local Institution
Orange, California, United States