CAFE Comparison of Atypicals in First Episode of Psychosis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00034892

Enrollment

Unknown

Registered

2002-05-03

Start date

2002-03-31

Completion date

2005-03-31

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders, Mental Health, Psychotic Disorders, Schizophrenia

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.

Interventions

DRUGOlanzapine, risperidone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 40 Years

Healthy volunteers

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026