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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of California, Los Angeles
Investigators
Principal Investigator: Stephen R. Marder, MD University of California, Los Angeles
  More Information

No publications provided

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: R01 MH41573, R01MH041573
Study First Received: September 13, 2005
Results First Received: May 21, 2010
Last Updated: May 20, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Olanzapine
Risperidone
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on July 26, 2015