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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.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00183625
  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
Behavioral: Social Skills Training
Drug: Olanzapine
Drug: Risperidone
Phase IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone Olanzapine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Functional outcome
  • quality of life

Estimated Enrollment: 160
Study Start Date: June 2000
Estimated Study Completion Date: September 2005
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Stephen R. Marder, MD University of California, Los Angeles
  More Information

Study ID Numbers: R01 MH41573, DSIR AT-SP
Study First Received: September 13, 2005
Last Updated: November 18, 2005
ClinicalTrials.gov Identifier: NCT00183625  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Antipsychotic Agents
Employment

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Olanzapine
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009