SchizophreniaPhase 4NCT00183625
Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients
A Phase 4 study testing Individual Placement and Support (Supported Employment), Social Skills Training and Olanzapine in people with Schizophrenia, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Individual Placement and Support (Supported Employment), Social Skills Training and Olanzapine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2000to Sep 2006
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia
- Candidate for maintenance schizophrenia treatment
- Willing to initiate and continue risperidone or olanzapine therapy for the duration of the study
Who cannot join
- Any serious medical problems other than schizophrenia that would interfere with the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
West Los Angeles Veterans Healthcare Center
Los Angeles, California, 90073
Greater Manchester Mental Health Center
Manchester, New Hampshire, 03104
About this study
Official title: The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Individual Placement and Support (Supported Employment), Social Skills Training, Olanzapine, Risperidone
- Keywords
- Antipsychotic Agents, Employment
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Placement and Support (Supported Employment)Behavioural
Social Skills TrainingBehavioural
OlanzapineDrug
RisperidoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Risperidone Plus Supported Employment | Active comparator | Not described Receives: Behavioral: Individual Placement and Support (Supported Employment); Drug: Risperidone |
| Olanzapine Plus Supported Employment | Active comparator | Not described Receives: Behavioral: Individual Placement and Support (Supported Employment); Drug: Olanzapine |
| Risperidone+Supported Employment+Skills | Active comparator | Not described Receives: Behavioral: Individual Placement and Support (Supported Employment); Behavioral: Social Skills Training; Drug: Risperidone |
| Olanzapine+Supported Employment+Skills | Active comparator | Not described Receives: Behavioral: Individual Placement and Support (Supported Employment); Behavioral: Social Skills Training; Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Weeks Worked
Measured: 24 months
Secondary outcomes (1)
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.
Measured: First 18 months of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2000
- Primary completionJun 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Stephen R. Marder, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183625
- Sponsor's protocol ID
- R01MH041573
- Other IDs
- R01MH041573
- Status last verified
- Nov 2005
- First submitted
- 13 Sep 2005
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes