SchizophreniaPhase 4NCT00203788
Improving Work Outcome in People With Recent-onset Schizophrenia
A Phase 4 study testing Individual Placement and Support, Workplace Fundamentals Module and Brokered Vocational Rehabilitation in people with Schizophrenia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will determine the effectiveness of combining antipsychotic medication with Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or Brokered Vocational Rehabilitation in facilitating the search for appropriate work or schooling and maintaining work or school… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Individual Placement and Support, Workplace Fundamentals Module and Brokered Vocational Rehabilitation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- May 1999to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- First major psychotic episode within 2 years of study entry
- RDC schizophrenia or schizoaffective disorder, mainly schizophrenic subtype
- Residence within commuting distance of UCLA
- Interest in trying to resume work or school
- Speaks English
Who cannot join
- Known neurological disorder
- Significant and habitual drug abuse or alcoholism within 6 months of psychotic episode or evidence that substance abuse will be a prominent factor in course of illness
- Mental retardation
- Treatment with risperidone is contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Neuropsychiatric Institute
Los Angeles, California, 90095-6968
About this study
Official title: Developmental Processes in Schizophrenic Disorders: Improving and Predicting Work Outcome in Recent-Onset Schizophrenia
This study will determine the effectiveness of combining antipsychotic medication with Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or Brokered Vocational Rehabilitation in facilitating the search for appropriate work or schooling and maintaining work or school activities in people with recent-onset schizophrenia.
Read the detailed description
The purpose of this protocol is to test, in recent-onset schizophrenia, the efficacy of a rehabilitative intervention that is designed to enhance the search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. Predictors of work outcome are being assessed in the context of this work rehabilitation and treatment with the second-generation antipsychotic medication, risperidone.
The Developmental Processes in Schizophrenic Disorders project involves an ongoing series of longitudinal follow-through studies of individuals with a recent onset of schizophrenia. The current protocol focuses particularly on processes affecting work outcome in this initial period after onset of schizophrenia, drawing on findings that link cognitive deficits in schizophrenia to functional outcome. The protocol is determining the effects on work outcome of a rehabilitative intervention designed to enhance search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. All entering patients are placed on a common antipsychotic medication, oral risperidone, and are provided clinical treatment by a psychiatrist and a case manager. Participating patients are randomly assigned to a combination of Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or to a Brokered Vocational Rehabilitation Model.
The protocol is examining the predictors of level of work functioning attained in the context of the work-focused intervention and maintenance on risperidone. Potential neurocognitive and environmental predictors of work and social functioning and clinical course are being examined. Aspects of early perceptual processing, allocation of attention, working memory, secondary verbal memory, and conceptual flexibility that are implicated as influences on functional outcome are assessed, as are potential stresses and supportive influences in the environment.
- Conditions
- Schizophrenia
- Being tested
- Individual Placement and Support, Workplace Fundamentals Module, Brokered Vocational Rehabilitation, Oral risperidone, Skills training group
- Keywords
- work outcome, supported employment, social skills training, risperidone, cognition, first-episode schizophrenia
- 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 SupportBehavioural
Supported education/employment
Workplace Fundamentals ModuleBehavioural
Group skills training on job/school topics
Brokered Vocational RehabilitationBehavioural
Vocational rehabilitation through traditional separate state-funded agency
Oral risperidoneDrug
Also called Risperdal
Risperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist
Skills training groupBehavioural
Group social skills training that did not focus primarily on work situations
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Individual Placement and Support Plus Workplace Fundamentals Module Receives: Behavioral: Individual Placement and Support; Behavioral: Workplace Fundamentals Module; Drug: Oral risperidone |
| 2 | Active comparator | Brokered Vocational Rehabilitation Receives: Behavioral: Brokered Vocational Rehabilitation; Drug: Oral risperidone; Behavioral: Skills training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to regular work or school during 18 month trial (SAS Work Section)
Measured: Every 3 months
Maintenance of work/school attendance over 18 months (SAS)
Measured: Every 3 months
Quality of work functioning on Work Behavior Inventory
Measured: Baseline, 6 months, 18 months
Secondary outcomes (4)
Cognitive performance on test battery
Measured: Baseline, 6 months, 18 months
Exacerbation or relapse of psychotic symptoms (BPRS)
Measured: Every 2 weeks
Retention in treatment
Measured: Every 3 months
Awareness of illness (SUMD-R)
Measured: Entry, 6 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 1999
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 87 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)
- Responsible party
- Principal investigator, Keith Nuechterlein, Ph.D., University of California, Los Angeles
- Investigators
- Keith H Nuechterlein, PhD, Principal investigator, University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203788
- Sponsor's protocol ID
- R01MH037705
- Other IDs
- R01MH037705, Janssen RIS-USA-67, DAHBR AD-P
- Status last verified
- May 2008
- First submitted
- 14 Sep 2005
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Nuechterlein KH, Subotnik KL, Ventura J, Gitlin MF, Green MF, Wallace CJ, Becker DR, Liberman RP, Drake RE, Mintz J. Advances in improving and predicting work outcome in recent-onset schizophrenia. Schizophrenia Bulletin 31(2): 530, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Processes in Schizophrenic Disorders: Improving and Predicting Work Outcome in Recent-Onset Schizophrenia
- ClinicalTrials.gov ID
- NCT00203788
- Acronym / sponsor ID
- R01MH037705
- Conditions
- Schizophrenia
- Keywords
- work outcome, supported employment, social skills training, risperidone, cognition, first-episode schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 1999
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness of combining antipsychotic medication with Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or Brokered Vocational Rehabilitation in facilitating the search for appropriate work or schooling and maintaining work or school activities in people with recent-onset schizophrenia.
Detailed description
The purpose of this protocol is to test, in recent-onset schizophrenia, the efficacy of a rehabilitative intervention that is designed to enhance the search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. Predictors of work outcome are being assessed in the context of this work rehabilitation and treatment with the second-generation antipsychotic medication, risperidone.
The Developmental Processes in Schizophrenic Disorders project involves an ongoing series of longitudinal follow-through studies of individuals with a recent onset of schizophrenia. The current protocol focuses particularly on processes affecting work outcome in this initial period after onset of schizophrenia, drawing on findings that link cognitive deficits in schizophrenia to functional outcome. The protocol is determining the effects on work outcome of a rehabilitative intervention designed to enhance search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. All entering patients are placed on a common antipsychotic medication, oral risperidone, and are provided clinical treatment by a psychiatrist and a case manager. Participating patients are randomly assigned to a combination of Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or to a Brokered Vocational Rehabilitation Model.
The protocol is examining the predictors of level of work functioning attained in the context of the work-focused intervention and maintenance on risperidone. Potential neurocognitive and environmental predictors of work and social functioning and clinical course are being examined. Aspects of early perceptual processing, allocation of attention, working memory, secondary verbal memory, and conceptual flexibility that are implicated as influences on functional outcome are assessed, as are potential stresses and supportive influences in the environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Individual Placement and Support, Behavioral: Workplace Fundamentals Module, Drug: Oral risperidoneIndividual Placement and Support Plus Workplace Fundamentals Module |
| 2 | Active comparator | Behavioral: Brokered Vocational Rehabilitation, Drug: Oral risperidone, Behavioral: Skills training groupBrokered Vocational Rehabilitation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- First major psychotic episode within 2 years of study entry
- RDC schizophrenia or schizoaffective disorder, mainly schizophrenic subtype
- Residence within commuting distance of UCLA
- Interest in trying to resume work or school
- Speaks English
Key exclusion criteria (4 listed)
- Known neurological disorder
- Significant and habitual drug abuse or alcoholism within 6 months of psychotic episode or evidence that substance abuse will be a prominent factor in course of illness
- Mental retardation
- Treatment with risperidone is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Placement and SupportSupported education/employment | Behavioural | 1 |
| Workplace Fundamentals ModuleGroup skills training on job/school topics | Behavioural | 1 |
| Brokered Vocational RehabilitationVocational rehabilitation through traditional separate state-funded agency | Behavioural | 2 |
| Oral risperidoneAlso: RisperdalRisperidone, starting target dosage was 6 mg, adjusted to level judged optimal by treating psychiatrist | Drug | 1, 2 |
| Skills training groupGroup social skills training that did not focus primarily on work situations | Behavioural | 2 |
Primary outcome
Return to regular work or school during 18 month trial (SAS Work Section)
Time frame: Every 3 months
Maintenance of work/school attendance over 18 months (SAS)
Time frame: Every 3 months
Quality of work functioning on Work Behavior Inventory
Time frame: Baseline, 6 months, 18 months
4 secondary outcomes
Cognitive performance on test battery
Time frame: Baseline, 6 months, 18 months
Exacerbation or relapse of psychotic symptoms (BPRS)
Time frame: Every 2 weeks
Retention in treatment
Time frame: Every 3 months
Awareness of illness (SUMD-R)
Time frame: Entry, 6 months, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- BackgroundNuechterlein KH, Subotnik KL, Ventura J, Gitlin MF, Green MF, Wallace CJ, Becker DR, Liberman RP, Drake RE, Mintz J. Advances in improving and predicting work outcome in recent-onset schizophrenia. Schizophrenia Bulletin 31(2): 530, 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith H Nuechterlein, PhD principal investigator
University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Individual Placement and Support, Workplace Fundamentals Module and Brokered Vocational Rehabilitation in people with Schizophrenia, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to regular work or school during 18 month trial (SAS Work Section) (time frame: Every 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00203788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.