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Clinical Trials/NCT00237939
NCT00237939
Completed
Phase 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.1 site in 1 country1,200 target enrollmentSeptember 2002

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment
1200
Locations
1
Primary Endpoint
Clinical Global Impression-Improvement at endpoint
Status
Completed
Last Updated
12 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 2002
End Date
November 2006
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Study Sites (1)

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