CAFE Comparison of Atypicals in First Episode of Psychosis

NCT ID: NCT00034892

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2005-03-31

Brief Summary

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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

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Conditions

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Schizophrenia Psychotic Disorders Mental Health Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Olanzapine, risperidone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Locations

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Stanford, California, United States

Site Status

Miami, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Augusta, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Boston, Massachusetts, United States

Site Status

Worcester, Massachusetts, United States

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Minneapolis, Minnesota, United States

Site Status

St Louis, Missouri, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Brooklyn, New York, United States

Site Status

New York, New York, United States

Site Status

Butner, North Carolina, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Cleveland, Ohio, United States

Site Status

Kettering, Ohio, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Conroe, Texas, United States

Site Status

Research Site

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Calgary, Alberta, Canada

Site Status

Halifax, Nova Scotia, Canada

Site Status

Countries

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United States Canada

References

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Perkins DO, Gu H, Weiden PJ, McEvoy JP, Hamer RM, Lieberman JA; Comparison of Atypicals in First Episode study group. Predictors of treatment discontinuation and medication nonadherence in patients recovering from a first episode of schizophrenia, schizophreniform disorder, or schizoaffective disorder: a randomized, double-blind, flexible-dose, multicenter study. J Clin Psychiatry. 2008 Jan;69(1):106-13. doi: 10.4088/jcp.v69n0114.

Reference Type DERIVED
PMID: 18312044 (View on PubMed)

Keefe RS, Sweeney JA, Gu H, Hamer RM, Perkins DO, McEvoy JP, Lieberman JA. Effects of olanzapine, quetiapine, and risperidone on neurocognitive function in early psychosis: a randomized, double-blind 52-week comparison. Am J Psychiatry. 2007 Jul;164(7):1061-71. doi: 10.1176/ajp.2007.164.7.1061.

Reference Type DERIVED
PMID: 17606658 (View on PubMed)

McEvoy JP, Lieberman JA, Perkins DO, Hamer RM, Gu H, Lazarus A, Sweitzer D, Olexy C, Weiden P, Strakowski SD. Efficacy and tolerability of olanzapine, quetiapine, and risperidone in the treatment of early psychosis: a randomized, double-blind 52-week comparison. Am J Psychiatry. 2007 Jul;164(7):1050-60. doi: 10.1176/ajp.2007.164.7.1050.

Reference Type DERIVED
PMID: 17606657 (View on PubMed)

Other Identifiers

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5077IL/0114

Identifier Type: -

Identifier Source: org_study_id

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