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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Individual Placement and Support (Supported Employment)
Social Skills Training
Olanzapine
Risperidone
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Antipsychotic Agents, Employment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Los Angeles Veterans Healthcare Center
  • Greater Manchester Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Risperidone Plus Supported Employment

Olanzapine Plus Supported Employment

Risperidone+Supported Employment+Skills

Olanzapine+Supported Employment+Skills

Arm Description

Outcomes

Primary Outcome Measures

Total Weeks Worked

Secondary Outcome Measures

Body Mass Index
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.

Full Information

First Posted
September 13, 2005
Last Updated
May 20, 2015
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH), US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00183625
Brief Title
Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients
Official Title
The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH), US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Antipsychotic Agents, Employment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risperidone Plus Supported Employment
Arm Type
Active Comparator
Arm Title
Olanzapine Plus Supported Employment
Arm Type
Active Comparator
Arm Title
Risperidone+Supported Employment+Skills
Arm Type
Active Comparator
Arm Title
Olanzapine+Supported Employment+Skills
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Individual Placement and Support (Supported Employment)
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Type
Drug
Intervention Name(s)
Risperidone
Primary Outcome Measure Information:
Title
Total Weeks Worked
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
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.
Time Frame
First 18 months of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen R. Marder, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Los Angeles Veterans Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Greater Manchester Mental Health Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03104
Country
United States

12. IPD Sharing Statement

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

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