CAFE Comparison of Atypicals in First Episode of Psychosis

Phase 3

Completed

• Conditions: Schizophrenia; Psychotic Disorders; Mental Health; Mental Disorders

• Registration Number: NCT00034892
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to compare the effectiveness, tolerability, and efficacy of the currently available atypical antipsychotic drugs olanzapine (2.5-20 mg/day), quetiapine (100-800 mg/day) and risperidone (0.5-4 mg/day) in patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder who are experiencing their first psychotic episode.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients must meet criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder with psychotic symptoms lasting 1-60 months
• Psychotic symptoms must have persisted at least one month, and not more thn 5 years (60 months)
• Patients must have no previous history of drug treatment (greater than a total of 16 weeks) with antipsychotics

Exclusion Criteria

• Patients with history of psychotic disorder with recovery period of at least 3 months
• Female patients who are pregnant or nursing
• Patients with a known history of mental retardation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Research Site; 🇺🇸 Dallas, Texas, United States