CAFE Comparison of Atypicals in First Episode of Psychosis

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.

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Key information

Conditions

Schizophrenia Behavior Mental Disorders Mental Health Personal Satisfaction Psychological Well-Being Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine, risperidone

Drug

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

University of North Carolina

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2005
First posted: May 3, 2002
Registry last updated: Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed