CAFE Comparison of Atypicals in First Episode of Psychosis
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ClinicalTrials.gov Identifier: NCT00034892 |
Recruitment Status
:
Completed
First Posted
: May 3, 2002
Last Update Posted
: January 4, 2013
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Sponsor:
AstraZeneca
Collaborator:
University of North Carolina
Information provided by:
AstraZeneca
Tracking Information | |||
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First Submitted Date ICMJE | May 2, 2002 | ||
First Posted Date ICMJE | May 3, 2002 | ||
Last Update Posted Date | January 4, 2013 | ||
Study Start Date ICMJE | March 2002 | ||
Actual Primary Completion Date | March 2005 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | Complete list of historical versions of study NCT00034892 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | CAFE Comparison of Atypicals in First Episode of Psychosis | ||
Official Title ICMJE | Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52-Week Comparison | ||
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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Olanzapine, risperidone | ||
Study Arms | Not Provided | ||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date | March 2005 | ||
Actual Primary Completion Date | March 2005 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 16 Years to 40 Years (Child, Adult) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00034892 | ||
Other Study ID Numbers ICMJE | 5077IL/0114 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | AstraZeneca | ||
Collaborators ICMJE | University of North Carolina | ||
Investigators ICMJE | Not Provided | ||
PRS Account | AstraZeneca | ||
Verification Date | January 2013 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |