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CAFE Comparison of Atypicals in First Episode of Psychosis
This study has been completed.
Sponsor:
AstraZeneca
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
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | May 2, 2002 | ||
| Last Updated Date | January 3, 2013 | ||
| Start Date ICMJE | March 2002 | ||
| 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 | ||
| Completion Date | March 2005 | ||
| 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 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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