A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00237939
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-10-11
• Study First Submitted QC: 2005-10-11
• Study First Posted: 2005-10-13
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2007-10
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression-Improvement at endpoint

Secondary Outcome Measures

Name	Time	Method
Patients' and caregivers' medication preference

Trial Locations

Locations (1)

Local Institution; 🇪🇸 Sevilla, Spain