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

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Behavioral: Individual Placement and Support (Supported Employment); Drug: Risperidone; Drug: Olanzapine; Behavioral: Social Skills Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00183625

R01MH041573 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 4 patient groups

Risperidone Plus Supported Employment

Active Comparator group

Treatment:

Behavioral: Individual Placement and Support (Supported Employment)

Drug: Risperidone

Olanzapine Plus Supported Employment

Active Comparator group

Treatment:

Behavioral: Individual Placement and Support (Supported Employment)

Drug: Olanzapine

Risperidone+Supported Employment+Skills

Active Comparator group

Treatment:

Behavioral: Social Skills Training

Behavioral: Individual Placement and Support (Supported Employment)

Drug: Risperidone

Olanzapine+Supported Employment+Skills

Active Comparator group

Treatment:

Behavioral: Social Skills Training

Behavioral: Individual Placement and Support (Supported Employment)

Drug: Olanzapine