The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training in Schizophrenia Patients Taking Risperidone or Olanzapine
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | November 18, 2005 | ||||
| Start Date ICMJE | June 2000 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Functional outcome and quality of life; measured at Month 7 and Years 1 and 2 | ||||
| Change History | Complete list of historical versions of study NCT00183625 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Vocational outcome; measured at Month 7 and Years 1 and 2 | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training in Schizophrenia Patients Taking Risperidone or Olanzapine | ||||
| Official Title ICMJE | The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training | ||||
| Brief Summary | This study will compare employment support with behavioral skills training to employment support alone in schizophrenia patients taking either risperidone or olanzapine to determine which is more effective in helping the patients maintain a job. |
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| Detailed Description | Schizophrenia is a severe mental disorder characterized by disorganized thoughts, difficulty concentrating, and hallucinations. Individuals with schizophrenia often experience reduced emotional, social, and occupational functioning. Data indicate that antipsychotic drug treatment and occupational training and support may be effective in helping people with schizophrenia maintain a stable job. Risperidone and olanzapine are antipsychotic drugs; participants in this study will be taking either risperidone or olanzapine for the duration of the study. This study will provide schizophrenia patients with employment support alone or with behavioral skills training to determine which combination is more effective in helping patients obtain and maintain a job. At study entry, participants will undergo a clinical and diagnostic evaluation to determine the severity of their schizophrenia. Participants will be tapered off their regular medication for schizophrenia over 4 weeks. At the end of Week 4, they will be randomly assigned to receive either risperidone or olanzapine. Participants will then be assigned an Individual Placement and Support (IPS) specialist to assist them in finding a job. After participants secure a job, they will be randomly assigned to receive IPS either alone or with the Workplace Fundamentals Skills Training Module for 2 years. Participants' risperidone or olanzapine treatment will continue during this 2-year period. Participants will have clinic visits at study entry and Months 7, 12, and 24. At each visit, participants will complete questionnaires and will be interviewed about their schizophrenia symptoms and occupational functioning. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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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 | 160 | ||||
| Completion Date | September 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 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 Number ICMJE | NCT00183625 | ||||
| Other Study ID Numbers ICMJE | R01 MH41573, DSIR AT-SP | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | November 2005 | ||||
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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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