Schizophrenia
Conditions
Keywords
Antipsychotic Agents, Employment
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.
Interventions
BEHAVIORALIndividual Placement and Support (Supported Employment)
BEHAVIORALSocial Skills Training
DRUGOlanzapine
DRUGRisperidone
Sponsors
University of California, Los Angeles
National Institute of Mental Health (NIMH)
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Weeks Worked | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | First 18 months of study | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephen R. Marder, MD
University of California, Los Angeles
Participant flow
Recruitment details
Patients recruited at the Manchester Mental Health Center, Greater Los Angeles VA, and UCLA Semel Institute
Participants by arm
| Arm | Count |
|---|---|
| Risperidone Treatment | 55 |
| Olanzapine Treatment | 52 |
| Total | 107 |
Baseline characteristics
| Characteristic | Risperidone Treatment | Olanzapine Treatment | Total |
|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 10.4 | 42.2 years STANDARD_DEVIATION 9.4 | 42.0 years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 45 Participants | 43 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 0 / 55 | 0 / 52 |
| serious Total, serious adverse events | 16 / 55 | 12 / 52 |
Outcome results
Primary
Total Weeks Worked
Time frame: 24 months
Population: Data were analyzed for work condition (IPS with or without WIPS) and not for medication (risperidone or olanzapine)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Placement and Support (IPS) | Total Weeks Worked | 51.53 Weeks | Standard Deviation 31.15 |
| Individual Placement and Support With Workplace Fundamentals | Total Weeks Worked | 41.37 Weeks | Standard Deviation 37.46 |
p-value: 0.66Regression, Linear
Secondary
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.
Time frame: First 18 months of study
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Individual Placement and Support (IPS) | Body Mass Index | 29.21 kg/m^2 | Standard Error 0.99 |
| Individual Placement and Support With Workplace Fundamentals | Body Mass Index | 30.4 kg/m^2 | Standard Error 1.04 |
Comparison: Mixed effects regression of body mass index on medication group (risp or olanz), time (in days over first 18 months of study) and a group by time interaction with site and baseline timepoint indicators as covariates. The model included a random slope and intercept for time.p-value: 0.0176Mixed Models Analysis