Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
VA Office of Research and Development
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00183625
First received: September 13, 2005
Last updated: May 20, 2015
Last verified: November 2005
Results First Received: May 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Behavioral: Individual Placement and Support (Supported Employment)
Behavioral: Social Skills Training
Drug: Olanzapine
Drug: Risperidone

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited at the Manchester Mental Health Center, Greater Los Angeles VA, and UCLA Semel Institute

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Risperidone Plus Supported Employment Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
Olanzapine Plus Supported Employment Individual Placement and Support plus Olanzapine. Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
Risperidone + Supported Employment + Skills Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
Olanzapine + Supported Employment + Skills Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.

Participant Flow:   Overall Study
    Risperidone Plus Supported Employment   Olanzapine Plus Supported Employment   Risperidone + Supported Employment + Skills   Olanzapine + Supported Employment + Skills
STARTED   27   28   28   24 
Obtained Employment   21   18   14   14 
COMPLETED   9   10   9   10 
NOT COMPLETED   18   18   19   14 
Withdrawal by Subject                18                18                19                14 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Risperidone Treatment No text entered.
Olanzapine Treatment No text entered.
Total Total of all reporting groups

Baseline Measures
   Risperidone Treatment   Olanzapine Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   52   107 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.8  (10.4)   42.2  (9.4)   42.0  (9.9) 
Gender 
[Units: Participants]
     
Female   10   9   19 
Male   45   43   88 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Weeks Worked   [ Time Frame: 24 months ]

2.  Secondary:   Body Mass Index   [ Time Frame: First 18 months of study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Stephen R. Marder, M.D.
Organization: Semel Institute at UCLA
phone: 310-268-3647
e-mail: marder@ucla.edu



Responsible Party: Stephen R. Marder, M.D., Semel Institute, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00183625     History of Changes
Other Study ID Numbers: R01MH041573 ( US NIH Grant/Contract Award Number )
Study First Received: September 13, 2005
Results First Received: May 21, 2010
Last Updated: May 20, 2015
Health Authority: United States: Federal Government