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Clinical Trials/NCT00183625
NCT00183625
Completed
Phase 4

The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training

University of California, Los Angeles2 sites in 1 country107 target enrollmentJune 1, 2000

Overview

Phase
Phase 4
Intervention
Individual Placement and Support (Supported Employment)
Conditions
Schizophrenia
Sponsor
University of California, Los Angeles
Enrollment
107
Locations
2
Primary Endpoint
Total Weeks Worked
Status
Completed
Last Updated
2 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2000
End Date
September 1, 2006
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Risperidone Plus Supported Employment

Intervention: Individual Placement and Support (Supported Employment)

Risperidone Plus Supported Employment

Intervention: Risperidone

Olanzapine Plus Supported Employment

Intervention: Individual Placement and Support (Supported Employment)

Olanzapine Plus Supported Employment

Intervention: Olanzapine

Risperidone+Supported Employment+Skills

Intervention: Individual Placement and Support (Supported Employment)

Risperidone+Supported Employment+Skills

Intervention: Social Skills Training

Risperidone+Supported Employment+Skills

Intervention: Risperidone

Olanzapine+Supported Employment+Skills

Intervention: Individual Placement and Support (Supported Employment)

Olanzapine+Supported Employment+Skills

Intervention: Social Skills Training

Olanzapine+Supported Employment+Skills

Intervention: Olanzapine

Outcomes

Primary Outcomes

Total Weeks Worked

Time Frame: 24 months

Secondary Outcomes

  • Body Mass Index(First 18 months of study)

Study Sites (2)

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