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NCT00034892 Clinical Trial

CAFE Comparison of Atypicals in First Episode of Psychosis

Schizophrenia Clinical Trial

Official title:
Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week Comparison

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00034892
Other study ID # 5077IL/0114
Secondary ID
Status Completed
Phase Phase 3
First received May 2, 2002
Last updated January 3, 2013
Start date March 2002
Est. completion date March 2005

Study information
Verified date January 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date March 2005
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 40 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Olanzapine, risperidone

Locations
Country Name City State
United States Research Site Dallas Texas

Sponsors (2)
Lead Sponsor Collaborator
AstraZeneca University of North Carolina

Countries where clinical trial is conducted

United States,  Canada, 

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