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The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training in Schizophrenia Patients Taking Risperidone or Olanzapine

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183625
First received: September 13, 2005
Last updated: November 18, 2005
Last verified: November 2005

September 13, 2005
November 18, 2005
June 2000
Not Provided
  • Functional outcome
  • quality of life
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
Not Provided
Vocational outcome; measured at Month 7 and Years 1 and 2
Not Provided
Not Provided
 
The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training in Schizophrenia Patients Taking Risperidone or Olanzapine
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
Primary Purpose: Treatment
Schizophrenia
  • Behavioral: Individual Placement and Support
  • Behavioral: Social Skills Training
  • Drug: Olanzapine
  • Drug: Risperidone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
September 2005
Not Provided

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, DSIR AT-SP
Not Provided
Not Provided
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Stephen R. Marder, MD University of California, Los Angeles
National Institute of Mental Health (NIMH)
November 2005

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