Clinical trial NCT00183625: Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients
Official title: The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Antipsychotic Agents
Employment
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: US Department of Veterans Affairs
First posted: 2005-09-16
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Weeks Worked
timeFrame: 24 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: First 18 months of study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: West Los Angeles Veterans Healthcare Center
state: California
city: Manchester
country: United States
facility: Greater Manchester Mental Health Center
state: New Hampshire
Study officials:
affiliation: University of California, Los Angeles
name: Stephen R. Marder, MD
role: PRINCIPAL_INVESTIGATOR
References: