Clinical trial NCT00203788: Improving Work Outcome in People With Recent-onset Schizophrenia
Official title: Developmental Processes in Schizophrenic Disorders: Improving and Predicting Work Outcome in Recent-Onset Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: work outcome
supported employment
social skills training
risperidone
cognition
first-episode schizophrenia
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-20
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Return to regular work or school during 18 month trial (SAS Work Section)
timeFrame: Every 3 months
measure: Maintenance of work/school attendance over 18 months (SAS)
timeFrame: Every 3 months
measure: Quality of work functioning on Work Behavior Inventory
timeFrame: Baseline, 6 months, 18 months
Secondary outcomes:
measure: Cognitive performance on test battery
timeFrame: Baseline, 6 months, 18 months
measure: Exacerbation or relapse of psychotic symptoms (BPRS)
timeFrame: Every 2 weeks
measure: Retention in treatment
timeFrame: Every 3 months
measure: Awareness of illness (SUMD-R)
timeFrame: Entry, 6 months, 18 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Neuropsychiatric Institute
state: California
Study officials:
affiliation: University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
name: Keith H Nuechterlein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.