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

NCT ID: NCT00183625

Last Updated: 2015-06-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2006-09-30

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Risperidone Plus Supported Employment

Group Type ACTIVE_COMPARATOR

Individual Placement and Support (Supported Employment)

Intervention Type BEHAVIORAL

Risperidone

Intervention Type DRUG

Olanzapine Plus Supported Employment

Group Type ACTIVE_COMPARATOR

Individual Placement and Support (Supported Employment)

Intervention Type BEHAVIORAL

Olanzapine

Intervention Type DRUG

Risperidone+Supported Employment+Skills

Group Type ACTIVE_COMPARATOR

Individual Placement and Support (Supported Employment)

Intervention Type BEHAVIORAL

Social Skills Training

Intervention Type BEHAVIORAL

Risperidone

Intervention Type DRUG

Olanzapine+Supported Employment+Skills

Group Type ACTIVE_COMPARATOR

Individual Placement and Support (Supported Employment)

Intervention Type BEHAVIORAL

Social Skills Training

Intervention Type BEHAVIORAL

Olanzapine

Intervention Type DRUG

Interventions

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Individual Placement and Support (Supported Employment)

Intervention Type BEHAVIORAL

Social Skills Training

Intervention Type BEHAVIORAL

Olanzapine

Intervention Type DRUG

Risperidone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Semel Institute, University of California, Los Angeles

Principal Investigators

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Stephen R. Marder, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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West Los Angeles Veterans Healthcare Center

Los Angeles, California, United States

Site Status

Greater Manchester Mental Health Center

Manchester, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH041573

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH041573

Identifier Type: NIH

Identifier Source: org_study_id

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