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Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients

Phase 4
Completed
Conditions
Schizophrenia
Interventions
Behavioral: Individual Placement and Support (Supported Employment)
Behavioral: Social Skills Training
Registration Number
NCT00183625
Lead Sponsor
University of California, Los Angeles
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
107
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Risperidone Plus Supported EmploymentIndividual Placement and Support (Supported Employment)-
Risperidone Plus Supported EmploymentRisperidone-
Olanzapine Plus Supported EmploymentIndividual Placement and Support (Supported Employment)-
Olanzapine Plus Supported EmploymentOlanzapine-
Olanzapine+Supported Employment+SkillsIndividual Placement and Support (Supported Employment)-
Risperidone+Supported Employment+SkillsIndividual Placement and Support (Supported Employment)-
Risperidone+Supported Employment+SkillsSocial Skills Training-
Olanzapine+Supported Employment+SkillsSocial Skills Training-
Olanzapine+Supported Employment+SkillsOlanzapine-
Risperidone+Supported Employment+SkillsRisperidone-
Primary Outcome Measures
NameTimeMethod
Total Weeks Worked24 months
Secondary Outcome Measures
NameTimeMethod
Body Mass IndexFirst 18 months of study

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.

Trial Locations

Locations (2)

West Los Angeles Veterans Healthcare Center

🇺🇸

Los Angeles, California, United States

Greater Manchester Mental Health Center

🇺🇸

Manchester, New Hampshire, United States

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