Improving Work Outcome in People With Recent-onset Schizophrenia

NCT ID: NCT00203788

Last Updated: 2013-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2006-12-31

Brief Summary

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This study will determine the effectiveness of combining antipsychotic medication with Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or Brokered Vocational Rehabilitation in facilitating the search for appropriate work or schooling and maintaining work or school activities in people with recent-onset schizophrenia.

Detailed Description

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The purpose of this protocol is to test, in recent-onset schizophrenia, the efficacy of a rehabilitative intervention that is designed to enhance the search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. Predictors of work outcome are being assessed in the context of this work rehabilitation and treatment with the second-generation antipsychotic medication, risperidone.

The Developmental Processes in Schizophrenic Disorders project involves an ongoing series of longitudinal follow-through studies of individuals with a recent onset of schizophrenia. The current protocol focuses particularly on processes affecting work outcome in this initial period after onset of schizophrenia, drawing on findings that link cognitive deficits in schizophrenia to functional outcome. The protocol is determining the effects on work outcome of a rehabilitative intervention designed to enhance search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. All entering patients are placed on a common antipsychotic medication, oral risperidone, and are provided clinical treatment by a psychiatrist and a case manager. Participating patients are randomly assigned to a combination of Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or to a Brokered Vocational Rehabilitation Model.

The protocol is examining the predictors of level of work functioning attained in the context of the work-focused intervention and maintenance on risperidone. Potential neurocognitive and environmental predictors of work and social functioning and clinical course are being examined. Aspects of early perceptual processing, allocation of attention, working memory, secondary verbal memory, and conceptual flexibility that are implicated as influences on functional outcome are assessed, as are potential stresses and supportive influences in the environment.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Individual Placement and Support Plus Workplace Fundamentals Module

Group Type EXPERIMENTAL

Individual Placement and Support

Intervention Type BEHAVIORAL

Supported education/employment

Workplace Fundamentals Module

Intervention Type BEHAVIORAL

Group skills training on job/school topics

Oral risperidone

Intervention Type DRUG

Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist

2

Brokered Vocational Rehabilitation

Group Type ACTIVE_COMPARATOR

Brokered Vocational Rehabilitation

Intervention Type BEHAVIORAL

Vocational rehabilitation through traditional separate state-funded agency

Oral risperidone

Intervention Type DRUG

Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist

Skills training group

Intervention Type BEHAVIORAL

Group social skills training that did not focus primarily on work situations

Interventions

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Individual Placement and Support

Supported education/employment

Intervention Type BEHAVIORAL

Workplace Fundamentals Module

Group skills training on job/school topics

Intervention Type BEHAVIORAL

Brokered Vocational Rehabilitation

Vocational rehabilitation through traditional separate state-funded agency

Intervention Type BEHAVIORAL

Oral risperidone

Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist

Intervention Type DRUG

Skills training group

Group social skills training that did not focus primarily on work situations

Intervention Type BEHAVIORAL

Other Intervention Names

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Risperdal

Eligibility Criteria

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Inclusion Criteria

* First major psychotic episode within 2 years of study entry
* RDC schizophrenia or schizoaffective disorder, mainly schizophrenic subtype
* Residence within commuting distance of UCLA
* Interest in trying to resume work or school
* Speaks English

Exclusion Criteria

* Known neurological disorder
* Significant and habitual drug abuse or alcoholism within 6 months of psychotic episode or evidence that substance abuse will be a prominent factor in course of illness
* Mental retardation
* Treatment with risperidone is contraindicated
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Keith Nuechterlein, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith H Nuechterlein, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences

Locations

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UCLA Neuropsychiatric Institute

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Nuechterlein KH, Subotnik KL, Ventura J, Gitlin MF, Green MF, Wallace CJ, Becker DR, Liberman RP, Drake RE, Mintz J. Advances in improving and predicting work outcome in recent-onset schizophrenia. Schizophrenia Bulletin 31(2): 530, 2005.

Reference Type BACKGROUND

Other Identifiers

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R01MH037705

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Janssen RIS-USA-67

Identifier Type: -

Identifier Source: secondary_id

DAHBR AD-P

Identifier Type: -

Identifier Source: secondary_id

R01MH037705

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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