The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training in Schizophrenia Patients Taking Risperidone or Olanzapine
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Behavioral: Individual Placement and Support Behavioral: Social Skills Training Drug: Olanzapine Drug: Risperidone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training |
- Functional outcome
- quality of life
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2000 |
| Estimated Study Completion Date: | September 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of schizophrenia
- Candidate for maintenance schizophrenia treatment
- Willing to initiate and continue risperidone or olanzapine therapy for the duration of the study
Exclusion Criteria:
- Any serious medical problems other than schizophrenia that would interfere with the study
Contacts and Locations| United States, California | |
| West Los Angeles Veterans Healthcare Center | |
| Los Angeles, California, United States, 90073 | |
| United States, New Hampshire | |
| Greater Manchester Mental Health Center | |
| Manchester, New Hampshire, United States, 03104 | |
| Principal Investigator: | Stephen R. Marder, MD | University of California, Los Angeles |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00183625 History of Changes |
| Other Study ID Numbers: | R01 MH41573, DSIR AT-SP |
| Study First Received: | September 13, 2005 |
| Last Updated: | November 18, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Antipsychotic Agents Employment |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Risperidone Olanzapine Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013