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| Tracking Information | |||||
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| First Received Date ICMJE | November 2, 1999 | ||||
| Last Updated Date | February 19, 2009 | ||||
| Start Date ICMJE | September 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00000374 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment for First-Episode Schizophrenia | ||||
| Official Title ICMJE | Preventing Morbidity in First-Episode Schizophrenia | ||||
| Brief Summary | This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia. |
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| Detailed Description | The goal of the study is to prevent morbidity in first-episode schizophrenia using second-generation antipsychotic drugs: olanzapine, risperidone. Long-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications. However, in the years immediately following this initial good response, morbidity increases. Relapses, often multiple ones, are the rule and are usually precipitated by medication noncompliance. There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains. However, these newer agents have been studied primarily in chronic and/or treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another. First episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years. Outcome measures for the initial episode include psychopathology (positive, negative, and affective symptoms), side effects, neurocognition (executive function, memory, and attention), social and occupational function and service utilization. The effects on long-term course are measured in terms of frequency and timing of relapses, level of recovery from subsequent episodes and prospectively assessed course of psychopathology, neurocognitive function, social/vocational function, and service utilization. For information on a related study, please follow this link: http://clinicaltrials.gov/show/NCT00320671 |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized | ||||
| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE |
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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 ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 40 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00000374 | ||||
| Responsible Party | Delbert Robinson, MD / Principal Investigator, The Zucker Hillside Hospital | ||||
| Study ID Numbers ICMJE | R01 MH060004-01, DSIR 83-ATAP | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | The Zucker Hillside Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2009 | ||||
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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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