NCT00203788

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started May 1999

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 30, 2013

Status Verified

May 1, 2008

Enrollment Period

7.6 years

First QC Date

September 14, 2005

Last Update Submit

July 28, 2013

Conditions

Schizophrenia

Keywords

work outcomesupported employmentsocial skills trainingrisperidonecognitionfirst-episode schizophrenia

Outcome Measures

Primary Outcomes (3)

  • Return to regular work or school during 18 month trial (SAS Work Section)

    Every 3 months

  • Maintenance of work/school attendance over 18 months (SAS)

    Every 3 months

  • Quality of work functioning on Work Behavior Inventory

    Baseline, 6 months, 18 months

Secondary Outcomes (4)

  • Cognitive performance on test battery

    Baseline, 6 months, 18 months

  • Exacerbation or relapse of psychotic symptoms (BPRS)

    Every 2 weeks

  • Retention in treatment

    Every 3 months

  • Awareness of illness (SUMD-R)

    Entry, 6 months, 18 months

Study Arms (2)

1

EXPERIMENTAL

Individual Placement and Support Plus Workplace Fundamentals Module

Behavioral: Individual Placement and SupportBehavioral: Workplace Fundamentals ModuleDrug: Oral risperidone

2

ACTIVE COMPARATOR

Brokered Vocational Rehabilitation

Behavioral: Brokered Vocational RehabilitationDrug: Oral risperidoneBehavioral: Skills training group

Interventions

Individual Placement and SupportBEHAVIORAL

Supported education/employment

1
Workplace Fundamentals ModuleBEHAVIORAL

Group skills training on job/school topics

1
Brokered Vocational RehabilitationBEHAVIORAL

Vocational rehabilitation through traditional separate state-funded agency

2
Oral risperidoneDRUG

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

Also known as: Risperdal
12
Skills training groupBEHAVIORAL

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

2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Neuropsychiatric Institute

Los Angeles, California, 90095-6968, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Palliative CareRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Keith H Nuechterlein, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

May 1, 1999

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

July 30, 2013

Record last verified: 2008-05

Locations

US(1)