Trial Outcomes & Findings for Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients (NCT NCT00183625)
NCT ID: NCT00183625
Last Updated: 2026-02-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
107 participants
Primary outcome timeframe
24 months
Results posted on
2026-02-09
Participant Flow
Patients recruited at the Manchester Mental Health Center, Greater Los Angeles VA, and UCLA Semel Institute
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
28
|
24
|
|
Overall Study
Obtained employment
|
21
|
18
|
14
|
14
|
|
Overall Study
COMPLETED
|
9
|
10
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
18
|
18
|
19
|
14
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
18
|
19
|
14
|
Baseline Characteristics
Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients
Baseline characteristics by cohort
| Measure |
Risperidone Treatment
n=55 Participants
|
Olanzapine Treatment
n=52 Participants
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 10.4 • n=55 Participants
|
42.2 years
STANDARD_DEVIATION 9.4 • n=52 Participants
|
42.0 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=55 Participants
|
9 Participants
n=52 Participants
|
19 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=55 Participants
|
43 Participants
n=52 Participants
|
88 Participants
n=107 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Data were analyzed for work condition (IPS with or without WIPS) and not for medication (risperidone or olanzapine)
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=39 Participants
IPS alone for risperidone and olanzapine subjects
|
Individual Placement and Support With Workplace Fundamentals
n=28 Participants
Olanzapine and Risperidone Patients included.
|
|---|---|---|
|
Total Weeks Worked
|
51.53 Weeks
Standard Deviation 31.15
|
41.37 Weeks
Standard Deviation 37.46
|
SECONDARY outcome
Timeframe: First 18 months of studyIntent 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.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=55 Participants
IPS alone for risperidone and olanzapine subjects
|
Individual Placement and Support With Workplace Fundamentals
n=52 Participants
Olanzapine and Risperidone Patients included.
|
|---|---|---|
|
Body Mass Index
|
29.21 kg/m^2
Standard Error .99
|
30.4 kg/m^2
Standard Error 1.04
|
Adverse Events
Risperidone Treatment
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Olanzapine Treatment
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Risperidone Treatment
n=55 participants at risk
|
Olanzapine Treatment
n=52 participants at risk
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
29.1%
16/55 • Number of events 34
|
23.1%
12/52 • Number of events 16
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place