Back to resultsCAFE Comparison of Atypicals in First Episode of Psychosis
Primary Purpose
Schizophrenia, Psychotic Disorders, Mental Health
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olanzapine, risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00034892
First Posted
May 2, 2002
Last Updated
January 3, 2013
Sponsor
AstraZeneca
Collaborators
University of North Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00034892
Brief Title
CAFE Comparison of Atypicals in First Episode of Psychosis
Official Title
Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week Comparison
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
Collaborators
University of North Carolina
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders, Mental Health, Mental Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Olanzapine, risperidone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Stanford
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Butner
State/Province
North Carolina
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Conroe
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Calgary
State/Province
Alberta
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18312044
Citation
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.
Results Reference
derived
PubMed Identifier
17606658
Citation
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.
Results Reference
derived
PubMed Identifier
17606657
Citation
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.
Results Reference
derived
Learn more about this trial
CAFE Comparison of Atypicals in First Episode of Psychosis
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