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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH041573 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| US Department of Veterans Affairs | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risperidone Plus Supported Employment | Active Comparator |
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| Olanzapine Plus Supported Employment | Active Comparator |
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| Risperidone+Supported Employment+Skills | Active Comparator |
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| Olanzapine+Supported Employment+Skills | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual Placement and Support (Supported Employment) | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Weeks Worked | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Intent was to compare medication and not work group conditions. This was initially assessed at baseline and includes total time on either risperidone or olanzapine up to 18 months. | First 18 months of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen R. Marder, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Los Angeles Veterans Healthcare Center | Los Angeles | California | 90073 | United States | ||
| Greater Manchester Mental Health Center |
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Patients recruited at the Manchester Mental Health Center, Greater Los Angeles VA, and UCLA Semel Institute
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| ID | Title | Description |
|---|---|---|
| FG000 | Risperidone Plus Supported Employment | Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job. |
| FG001 | Olanzapine Plus Supported Employment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Social Skills Training | Behavioral |
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| Olanzapine | Drug |
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| Risperidone | Drug |
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| Manchester |
| New Hampshire |
| 03104 |
| United States |
Individual Placement and Support plus Olanzapine. Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job. |
| FG002 | Risperidone + Supported Employment + Skills | Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job. |
| FG003 | Olanzapine + Supported Employment + Skills | Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job. |
| Obtained employment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Risperidone Treatment | |
| BG001 | Olanzapine Treatment | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Total Weeks Worked | Data were analyzed for work condition (IPS with or without WIPS) and not for medication (risperidone or olanzapine) | Posted | Mean | Standard Deviation | Weeks | 24 months |
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| Secondary | Body Mass Index | Intent was to compare medication and not work group conditions. This was initially assessed at baseline and includes total time on either risperidone or olanzapine up to 18 months. | Posted | Least Squares Mean | Standard Error | kg/m^2 | First 18 months of study |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Risperidone Treatment | 16 | 55 | 0 | 55 | |||
| EG001 | Olanzapine Treatment | 12 | 52 | 0 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen R. Marder, M.D. | Semel Institute at UCLA | 310-268-3647 | marder@ucla.edu |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D016832 | Employment, Supported |
| D000077152 | Olanzapine |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D004651 | Employment |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D012050 | Rehabilitation, Vocational |
| D012046 | Rehabilitation |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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