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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00183625
First Posted: September 16, 2005
Last Update Posted: June 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
VA Office of Research and Development
Information provided by:
University of California, Los Angeles
  Purpose
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.

Condition Intervention Phase
Schizophrenia Behavioral: Individual Placement and Support (Supported Employment) Behavioral: Social Skills Training Drug: Olanzapine Drug: Risperidone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Total Weeks Worked [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Body Mass Index [ Time Frame: First 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.


Enrollment: 107
Study Start Date: June 2000
Study Completion Date: September 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Risperidone Plus Supported Employment Behavioral: Individual Placement and Support (Supported Employment) Drug: Risperidone
Active Comparator: Olanzapine Plus Supported Employment Behavioral: Individual Placement and Support (Supported Employment) Drug: Olanzapine
Active Comparator: Risperidone+Supported Employment+Skills Behavioral: Individual Placement and Support (Supported Employment) Behavioral: Social Skills Training Drug: Risperidone
Active Comparator: Olanzapine+Supported Employment+Skills Behavioral: Individual Placement and Support (Supported Employment) Behavioral: Social Skills Training Drug: Olanzapine

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183625


Locations
United States, California
West Los Angeles Veterans Healthcare Center
Los Angeles, California, United States, 90073
United States, New Hampshire
Greater Manchester Mental Health Center
Manchester, New Hampshire, United States, 03104
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
VA Office of Research and Development
Investigators
Principal Investigator: Stephen R. Marder, MD University of California, Los Angeles
  More Information

Responsible Party: Stephen R. Marder, M.D., Semel Institute, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00183625     History of Changes
Other Study ID Numbers: R01MH041573 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: May 21, 2010
Results First Posted: June 10, 2015
Last Update Posted: June 10, 2015
Last Verified: November 2005

Keywords provided by University of California, Los Angeles:
Antipsychotic Agents
Employment

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators