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Tracking Information | |||||
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First Received Date † | April 6, 2001 | ||||
Last Updated Date | July 2, 2007 | ||||
Start Date † | December 2000 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00014001 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | CATIE- Schizophrenia Trial | ||||
Official Title † | Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial) | ||||
Brief Summary | The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate. |
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Detailed Description | This trial will consist of 1600 patients with schizophrenia for whom a medication change may be indicated for reasons of limited efficacy or tolerability. All patients will receive some psychosocial treatment through study participation. Research participants and their family members will be offered psychosocial interventions directed at improving patient and family understanding of the illness, decreasing the burden of illness in the family, maximizing treatment adherence, minimizing relapse, enhancing access to a range of community-based rehabilitative services and improving study retention. Phase I: Patients will be randomly assigned to one of five treatment conditions for up to 18 months:
Phase IA: 100 patients screened and found to have tardive dyskinesia who would otherwise be eligible for the study will be randomly assigned to one of the four atypical drugs in Phase IA. Phase IB: Patients who fail treatment with perphenazine in Phase I will be randomly assigned to olanzapine, quetiapine, or risperidone in Phase IB. Phase II: Patients who discontinue their initial assigned atypical antipsychotic treatment in Phase I, IA, or IB for any non-administrative reason will proceed to their second assigned treatment (third for Phase IB patients) and will be followed for up to the remainder of their 18-month participation, as follows:
Phase II will last at least 6 months, even if that means participants stay in the study for more than 18 months Phase III: Patients who discontinue Phase II will be recommended open treatment with the preferred regimen based on their treatment history in the study. The treatment options include clozapine, newer atypical antipsychotic (olanzapine, risperidone, quetiapine, ziprazidone, and aripiprazole), fluphenazine decanoate, perphenazine, and dual antipsychotic therapy using two of these drugs. Note: All treatments will be double-blinded in treatment Phases I and II except for clozapine. |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Uncontrolled, Crossover Assignment, Safety/Efficacy Study | ||||
Condition † | Schizophrenia | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 1600 | ||||
Completion Date | December 2004 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion
Exclusion
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00014001 | ||||
Responsible Party | |||||
Secondary IDs †† | N01MH90001-SZ, DSIR AT | ||||
Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Institute of Mental Health (NIMH) | ||||
Verification Date | October 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |