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CAFE Comparison of Atypicals in First Episode of Psychosis

This study has been completed.
University of North Carolina
Information provided by:
AstraZeneca Identifier:
First received: May 2, 2002
Last updated: January 3, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Psychotic Disorders
Mental Health
Mental Disorders
Drug: Olanzapine, risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week Comparison

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Study Start Date: March 2002
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00034892

  Show 26 Study Locations
Sponsors and Collaborators
University of North Carolina
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00034892     History of Changes
Other Study ID Numbers: 5077IL/0114
Study First Received: May 2, 2002
Last Updated: January 3, 2013

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on April 28, 2017