NCT00237939CompletedPhase 3
A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA)
Otsuka Pharmaceutical Development & Commercialization, Inc.20 sites in 5 countries1,200 target enrollmentStarted: September 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,200
- Locations
- 20
- Primary Endpoint
- Clinical Global Impression-Improvement at endpoint
Study Overview
Brief Summary
The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical DSM-IV diagnosis of schizophrenia
- •Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required
Exclusion Criteria
- •Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes
- •Prisoners or subjects compulsory detained
Outcomes
Primary Outcomes
Clinical Global Impression-Improvement at endpoint
Secondary Outcomes
- Patients' and caregivers' medication preference
Investigators
Study Sites (20)
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