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

This study has been completed.
Sponsor:
Collaborators:
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
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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
None

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
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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.
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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  
Number of Participants  
[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
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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
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  More Information
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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


No publications provided


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: R01 MH41573, R01MH041573
Study First Received: September 13, 2005
Results First Received: May 21, 2010
Last Updated: May 20, 2015
Health Authority: United States: Federal Government