Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Cognitive remediation (Behavioral); Health behavior training (Behavioral); Risperidone, administered orally (Drug); Risperidone, administered via injection (Drug); Individual Placement and Support (Behavioral)
Phase: Phase 4
Status: Completed
Sponsored by: University of California, Los Angeles Official(s) and/or principal investigator(s): Keith H. Nuechterlein, PhD, Principal Investigator, Affiliation: University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
Summary
This study will determine the effectiveness of various combinations of psychosocial therapy
and risperidone treatment in improving work or school performance in people with
first-episode schizophrenia.
Clinical Details
Official title: Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cognitive performance on test battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery plus additional measures)Work or school functioning (Global Functioning Scale: Role) Maintenance of work/school attendance (SAS) Quality of work or school functioning, as assessed by the Work Behavior Inventory (WBI) Medication adherence
Secondary outcome: Measured over 12 months: Exacerbation or relapse of psychotic symptoms, as assessed by the Brief Psychiatric Rating Scale (BPRS)Retention in treatment Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R) Increased motivation for work/school Improved coping strategies
Detailed description:
Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia
often experience hallucinations, delusions, thought disorders, and movement disorders. These
symptoms make it difficult to maintain a job, participate in school, and keep up self-care.
Proper treatment of first-episode schizophrenia may increase the chances of controlling
disease progression on a long-term basis. Antipsychotic medications, such as risperidone,
and psychosocial treatments, such as cognitive enhancement training and health behavior
training, are common, effective treatments for schizophrenia. This study will determine the
effectiveness of various combinations of psychosocial therapy and risperidone treatment in
improving work or school performance in people with first-episode schizophrenia.
Participants in this open label study will be randomly assigned to receive one of the
following four combinations of an antipsychotic medication and a psychosocial treatment:
cognitive enhancement training plus oral risperidone; cognitive enhancement training plus
long-acting injectable risperidone; health behavior training plus oral risperidone; or
health behavior training plus long-acting injectable risperidone. Cognitive enhancement
training will entail 2 hours per week of computer-assisted training targeted at improving
attention, memory, and problem-solving skills. Additionally, participants will attend a
weekly 1-hour group meeting to learn how to apply these skills to work and school
situations. Health behavior training will involve 3 hours per week of relaxation training,
nutrition education, and physical exercise to enhance wellness. Participants assigned to
receive oral risperidone will receive their medication in pill form at the dosage determined
to be optimal by the study psychiatrist. Participants assigned to receive injectable
risperidone will be given one injection every 2 weeks. Dosages will start at 25 mg per
injection and will be adjusted as needed.
Treatment will continue for 1 year following dosage stabilization, which typically occurs 2
to 3 months following study entry. For the first 6 months, participants assigned to receive
health behavior training will attend study visits once a week and participants assigned to
receive cognitive enhancement training will attend study visits twice a week. For the final
6 months, all participants will attend study visits twice weekly. At each visit,
participants will receive their assigned psychosocial treatment; attend group therapy; meet
with a case manager for counseling and assessment of symptoms, work functioning, and social
functioning; and meet with a psychiatrist to monitor medication response. Additional
cognitive and health behavior measures will be taken every 6 months to assess treatment
effectiveness.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of schizophrenia, schizoaffective disorder (depressed type), or
schizophreniform disorder
- First major episode of psychotic symptoms occurred within 2 years prior to study
entry
Exclusion Criteria:
- Neurological disorder or injury (e. g., encephalitis, epilepsy, traumatic brain
injury)
- Mental retardation (e. g., premorbid IQ less than 70)
- Significant alcohol or substance use during last 6 months
- Unable to complete research measures in English
- Any condition that may make risperidone use medically inadvisable
Locations and Contacts
Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, California 90095, United States
Additional Information
Starting date: March 2006
Last updated: March 27, 2013
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