NCT00095524CompletedPhase 3
A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.32 sites in 3 countries300 target enrollmentStarted: March 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 300
- Locations
- 32
- Primary Endpoint
- Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
Study Overview
Brief Summary
The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
Secondary Outcomes
- Assessment of metabolic laboratory measures
Investigators
Study Sites (32)
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