The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training in Schizophrenia Patients Taking Risperidone or Olanzapine
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.
Behavioral: Individual Placement and Support
Behavioral: Social Skills Training
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training|
- Functional outcome
- quality of life
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183625
|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|