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

Study Overview
=================
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.

Detailed Description
-----------------
Schizophrenia is a severe mental disorder characterized by disorganized thoughts, difficulty concentrating, and hallucinations. Individuals with schizophrenia often experience reduced emotional, social, and occupational functioning. Data indicate that antipsychotic drug treatment and occupational training and support may be effective in helping people with schizophrenia maintain a stable job. Risperidone and olanzapine are antipsychotic drugs; participants in this study will be taking either risperidone or olanzapine for the duration of the study. This study will provide schizophrenia patients with employment support alone or with behavioral skills training to determine which combination is more effective in helping patients obtain and maintain a job. At study entry, participants will undergo a clinical and diagnostic evaluation to determine the severity of their schizophrenia. Participants will be tapered off their regular medication for schizophrenia over 4 weeks. At the end of Week 4, they will be randomly assigned to receive either risperidone or olanzapine. Participants will then be assigned an Individual Placement and Support (IPS) specialist to assist them in finding a job. After participants secure a job, they will be randomly assigned to receive IPS either alone or with the Workplace Fundamentals Skills Training Module for 2 years. Participants' risperidone or olanzapine treatment will continue during this 2-year period. Participants will have clinic visits at study entry and Months 7, 12, and 24. At each visit, participants will complete questionnaires and will be interviewed about their schizophrenia symptoms and occupational functioning.

Official Title
-----------------
The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Individual Placement and Support (Supported Employment)
* Behavioral: Social Skills Training
* Drug: Olanzapine
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia Candidate for maintenance schizophrenia treatment Willing to initiate and continue risperidone or olanzapine therapy for the duration of the study Exclusion Criteria: Any serious medical problems other than schizophrenia that would interfere with the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Risperidone Plus Supported Employment<br> | Behavioral: Individual Placement and Support (Supported Employment)<br> <br> Drug: Risperidone<br> <br> |
| Active Comparator: Olanzapine Plus Supported Employment<br> | Behavioral: Individual Placement and Support (Supported Employment)<br> <br> Drug: Olanzapine<br> <br> |
| Active Comparator: Risperidone+Supported Employment+Skills<br> | Behavioral: Individual Placement and Support (Supported Employment)<br> <br> Behavioral: Social Skills Training<br> <br> Drug: Risperidone<br> <br> |
| Active Comparator: Olanzapine+Supported Employment+Skills<br> | Behavioral: Individual Placement and Support (Supported Employment)<br> <br> Behavioral: Social Skills Training<br> <br> Drug: Olanzapine<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Weeks Worked |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Intent was to compare medication and not work group conditions. This was initially assessed at baseline and includes total time on either risperidone or olanzapine up to 18 months. | First 18 months of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antipsychotic Agents, Employment