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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00183625
First received: September 13, 2005
Last updated: May 20, 2015
Last verified: November 2005

September 13, 2005
May 20, 2015
June 2000
June 2005   (final data collection date for primary outcome measure)
Total Weeks Worked [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Functional outcome and quality of life; measured at Month 7 and Years 1 and 2
Complete list of historical versions of study NCT00183625 on ClinicalTrials.gov Archive Site
Body Mass Index [ Time Frame: First 18 months of study ] [ Designated as safety issue: No ]
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.
Vocational outcome; measured at Month 7 and Years 1 and 2
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Behavioral: Individual Placement and Support (Supported Employment)
  • Behavioral: Social Skills Training
  • Drug: Olanzapine
  • Drug: Risperidone
  • Active Comparator: Risperidone Plus Supported Employment
    Interventions:
    • Behavioral: Individual Placement and Support (Supported Employment)
    • Drug: Risperidone
  • Active Comparator: Olanzapine Plus Supported Employment
    Interventions:
    • Behavioral: Individual Placement and Support (Supported Employment)
    • Drug: Olanzapine
  • Active Comparator: Risperidone+Supported Employment+Skills
    Interventions:
    • Behavioral: Individual Placement and Support (Supported Employment)
    • Behavioral: Social Skills Training
    • Drug: Risperidone
  • Active Comparator: Olanzapine+Supported Employment+Skills
    Interventions:
    • Behavioral: Individual Placement and Support (Supported Employment)
    • Behavioral: Social Skills Training
    • Drug: Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
September 2006
June 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183625
R01 MH41573, R01MH041573
Yes
Stephen R. Marder, M.D., Semel Institute, University of California, Los Angeles
University of California, Los Angeles
  • National Institute of Mental Health (NIMH)
  • Department of Veterans Affairs
Principal Investigator: Stephen R. Marder, MD University of California, Los Angeles
University of California, Los Angeles
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP