CAFE Comparison of Atypicals in First Episode of Psychosis
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| ClinicalTrials.gov Identifier: NCT00034892 |
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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
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Psychotic Disorders Mental Health Mental Disorders | Drug: Olanzapine, risperidone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| 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 |
| Study Start Date : | March 2002 |
| Actual Primary Completion Date : | March 2005 |
| Actual Study Completion Date : | March 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Schizophrenia
Information from the National Library of Medicine
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| Ages Eligible for Study: | 16 Years to 40 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034892
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00034892 |
| Other Study ID Numbers: |
5077IL/0114 |
| First Posted: | May 3, 2002 Key Record Dates |
| Last Update Posted: | January 4, 2013 |
| Last Verified: | January 2013 |
Additional relevant MeSH terms:
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Disease Schizophrenia Psychotic Disorders Mental Disorders Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders Olanzapine Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Selective Serotonin Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |