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

The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Olanzapine; Drug: Risperidone; Behavioral: Social Skills Training; Behavioral: Individual Placement and Support (Supported Employment)

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • West Los Angeles Veterans Healthcare Center
  • New Hampshire
    • Manchester, New Hampshire, United States, 03104
      • Greater Manchester Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Risperidone Plus Supported Employment	Drug: Risperidone; Behavioral: Individual Placement and Support (Supported Employment)
Active Comparator: Olanzapine Plus Supported Employment	Drug: Olanzapine; Behavioral: Individual Placement and Support (Supported Employment)
Active Comparator: Risperidone+Supported Employment+Skills	Drug: Risperidone; Behavioral: Social Skills Training; Behavioral: Individual Placement and Support (Supported Employment)
Active Comparator: Olanzapine+Supported Employment+Skills	Drug: Olanzapine; Behavioral: Social Skills Training; Behavioral: Individual Placement and Support (Supported Employment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Weeks Worked	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	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.	First 18 months of study

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH); US Department of Veterans Affairs
• Investigators: Principal Investigator: Stephen R. Marder, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: June 1, 2000
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimated): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Keywords: Antipsychotic Agents; Employment
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Pyrimidines; Patient Care; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Rehabilitation; Pyrimidinones; Benzazepines; Benzodiazepines; Employment; Rehabilitation, Vocational; Olanzapine; Risperidone; Palliative Care; Employment, Supported
• Other Study ID Numbers: R01MH041573 (U.S. NIH Grant/Contract)