Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 2, 2002
January 3, 2013
March 2002
March 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00034892 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
CAFE Comparison of Atypicals in First Episode of Psychosis
Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week Comparison

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Schizophrenia
  • Psychotic Disorders
  • Mental Health
  • Mental Disorders
Drug: Olanzapine, risperidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 2005
March 2005   (final data collection date for primary outcome measure)

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
Both
16 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00034892
5077IL/0114
Not Provided
Not Provided
AstraZeneca
University of North Carolina
Not Provided
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP