CAFE Comparison of Atypicals in First Episode of Psychosis

This study has been completed.
Sponsor:
Collaborator:
University of North Carolina
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00034892
First received: May 2, 2002
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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
Schizophrenia
Psychotic Disorders
Mental Health
Mental Disorders
Drug: Olanzapine, risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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)
  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034892

  Hide Study Locations
Locations
United States, California
Stanford, California, United States
United States, Florida
Miami, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Brooklyn, New York, United States
New York, New York, United States
United States, North Carolina
Butner, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Kettering, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Conroe, Texas, United States
Research Site
Dallas, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Canada, Alberta
Calgary, Alberta, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
AstraZeneca
University of North Carolina
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00034892     History of Changes
Other Study ID Numbers: 5077IL/0114
Study First Received: May 2, 2002
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes
Risperidone
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014