Status:
COMPLETED
Oral Aripiprazole Open-Label Rollover Study
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
13-18 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.
Eligibility Criteria
Inclusion
- Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia
Exclusion
- Patients with a co-morbid serious, uncontrolled systemic illness
- Patients with a significant risk of committing suicide
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01001702
Start Date
April 1 2006
End Date
July 1 2012
Last Update
September 27 2013
Active Locations (15)
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1
Study site
Buenos Aires, Argentina
2
Study site
Mendoza, Argentina
3
Study site
Split, Croatia
4
Study site
Hyderabad, India