NCT00183625

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

2 active sites

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

June 1, 2000

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

June 10, 2015

Completed
Last Updated

February 9, 2026

Status Verified

November 1, 2005

Enrollment Period

5 years

First QC Date

September 13, 2005

Results QC Date

May 21, 2010

Last Update Submit

January 20, 2026

Conditions

Keywords

Antipsychotic AgentsEmployment

Outcome Measures

Primary Outcomes (1)

  • Total Weeks Worked

    24 months

Secondary Outcomes (1)

  • Body Mass Index

    First 18 months of study

Study Arms (4)

Risperidone Plus Supported Employment

ACTIVE COMPARATOR
Behavioral: Individual Placement and Support (Supported Employment)Drug: Risperidone

Olanzapine Plus Supported Employment

ACTIVE COMPARATOR
Behavioral: Individual Placement and Support (Supported Employment)Drug: Olanzapine

Risperidone+Supported Employment+Skills

ACTIVE COMPARATOR
Behavioral: Individual Placement and Support (Supported Employment)Behavioral: Social Skills TrainingDrug: Risperidone

Olanzapine+Supported Employment+Skills

ACTIVE COMPARATOR
Behavioral: Individual Placement and Support (Supported Employment)Behavioral: Social Skills TrainingDrug: Olanzapine

Interventions

Olanzapine Plus Supported EmploymentOlanzapine+Supported Employment+SkillsRisperidone Plus Supported EmploymentRisperidone+Supported Employment+Skills
Olanzapine+Supported Employment+SkillsRisperidone+Supported Employment+Skills
Olanzapine Plus Supported EmploymentOlanzapine+Supported Employment+Skills
Risperidone Plus Supported EmploymentRisperidone+Supported Employment+Skills

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia
  • Candidate for maintenance schizophrenia treatment
  • Willing to initiate and continue risperidone or olanzapine therapy for the duration of the study

You may not qualify if:

  • Any serious medical problems other than schizophrenia that would interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West Los Angeles Veterans Healthcare Center

Los Angeles, California, 90073, United States

Location

Greater Manchester Mental Health Center

Manchester, New Hampshire, 03104, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Palliative CareEmployment, SupportedOlanzapineRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesEmploymentSocioeconomic FactorsPopulation CharacteristicsRehabilitation, VocationalRehabilitationBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Stephen R. Marder, M.D.
Organization
Semel Institute at UCLA

Study Officials

  • Stephen R. Marder, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2000

Primary Completion

June 1, 2005

Study Completion

September 1, 2006

Last Updated

February 9, 2026

Results First Posted

June 10, 2015

Record last verified: 2005-11

Locations