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| Descriptive Information Fields | |||||||||
| Brief Title † | Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia | ||||||||
| Official Title † | Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia | ||||||||
| Brief 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Cognitive performance on test battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery plus additional measures) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ] Return to work or school (SAS Work Section) [ Time Frame: Measured every 3 months for 1 year ] [ Designated as safety issue: No ] Maintenance of work/school attendance (SAS) [ Time Frame: Measured every 3 months for 1 year ] [ Designated as safety issue: No ] Quality of work or school functioning, as assessed by the Work Behavior Inventory (WBI) [ Time Frame: Measured every 2 months for 1 year ] [ Designated as safety issue: No ] Medication adherence [ Time Frame: Measured every 2 weeks for 1 year ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Measured over 12 months: Exacerbation or relapse of psychotic symptoms, as assessed by the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ] Retention in treatment [ Time Frame: Every 3 months ] [ Designated as safety issue: No ] Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R) [ Time Frame: Every 6 months ] [ Designated as safety issue: No ] Increased motivation for work/school [ Time Frame: Every 6 months ] [ Designated as safety issue: No ] Improved coping strategies [ Time Frame: Every 6 months ] [ Designated as safety issue: No ] |
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| Condition † | Schizophrenia | ||||||||
| Intervention † | Behavioral: Cognitive remediation Behavioral: Health behavior training Drug: Risperidone, administered orally Drug: Risperidone, administered via injection Behavioral: Individual Placement and Support |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 140 | ||||||||
| Start Date † | March 2006 | ||||||||
| Completion Date | March 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00333177 | ||||||||
| Organization ID | R01 MH37705-06 | ||||||||
| Secondary IDs †† | DAHBR AD-P | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | June 1, 2006 | ||||||||
| Last Updated Date | May 5, 2008 | ||||||||
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