Status:
COMPLETED
Aripiprazole Open-Label, Safety and Tolerability Study
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic o...
Eligibility Criteria
Inclusion
- Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode
Exclusion
- Patients with a co-morbid serious, uncontrolled systemic illness
- Patients with a significant risk of committing suicide
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00102518
Start Date
September 1 2004
End Date
February 1 2007
Last Update
August 31 2012
Active Locations (50)
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1
Local Institution
Birmingham, Alabama, United States
2
Local Institution
Little Rock, Arkansas, United States
3
Local Institution
Costa Mesa, California, United States
4
Local Institution
Fresno, California, United States