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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00333177 |
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.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Behavioral: Cognitive remediation Behavioral: Health behavior training Drug: Risperidone, administered orally Drug: Risperidone, administered via injection Behavioral: Individual Placement and Support |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia |
Estimated Enrollment: | 140 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Participants will receive cognitive remediation training plus injectable, long-acting risperidone.
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Behavioral: Cognitive remediation
Cognitive remediation training includes computerized cognitive training plus learning skills group.
Drug: Risperidone, administered via injection
Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed
Behavioral: Individual Placement and Support
Supported education/employment
|
2: Active Comparator
Participants will receive health behavior training plus injectable, long-acting risperidone.
|
Behavioral: Health behavior training
Health behavior training includes group skills training in nutrition, exercise, and relaxation.
Drug: Risperidone, administered via injection
Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed
Behavioral: Individual Placement and Support
Supported education/employment
|
3: Experimental
Participants will receive cognitive remediation training plus risperidone administered orally.
|
Behavioral: Cognitive remediation
Cognitive remediation training includes computerized cognitive training plus learning skills group.
Drug: Risperidone, administered orally
Oral risperidone at dosage judged optimal by treating psychiatrist
Behavioral: Individual Placement and Support
Supported education/employment
|
4: Active Comparator
Participants will receive health behavior training plus risperidone administered orally.
|
Behavioral: Health behavior training
Health behavior training includes group skills training in nutrition, exercise, and relaxation.
Drug: Risperidone, administered orally
Oral risperidone at dosage judged optimal by treating psychiatrist
Behavioral: Individual Placement and Support
Supported education/employment
|
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rosemary Collier, MA | 310-206-5090 | rcollier@mednet.ucla.edu |
Contact: Luana Turner, PsyD | 310-974-7340 | luana@ucla.edu |
United States, California | |
Semel Institute for Neuroscience and Human Behavior at UCLA | Recruiting |
Los Angeles, California, United States, 90095 | |
Principal Investigator: Keith H. Nuechterlein, PhD | |
Sub-Investigator: Kenneth L. Subotnik, PhD | |
Sub-Investigator: Joseph Ventura, PhD | |
Sub-Investigator: John Luo, MD |
Principal Investigator: | Keith H. Nuechterlein, PhD | University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences |
Responsible Party: | UCLA ( Keith H. Nuechterlein, PhD ) |
Study ID Numbers: | R01 MH37705-06, DAHBR AD-P |
Study First Received: | June 1, 2006 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00333177 |
Health Authority: | United States: Federal Government |
Schizoaffective Disorder, Depressed Type Schizophreniform Disorder First-Episode Schizophrenia Supported Employment |
Cognitive Remediation Health Behavior Training Antipsychotic Medication |
Schizophrenia Dopamine Depression Mental Disorders |
Risperidone Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |