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Sponsors and Collaborators: |
Manhattan Psychiatric Center Nathan Kline Institute for Psychiatric Research |
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Information provided by: | Manhattan Psychiatric Center |
ClinicalTrials.gov Identifier: | NCT00431223 |
This project is a novel exploratory research project to investigate changes in activation patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who received a 12-week computerized cognitive remediation (CRT) program. The hypothesis is that patients receiving CRT will show greater increase in activation patterns in the brain as compared to controls, and the degree of brain activation will correlate with improvements in working memory.
Condition | Intervention |
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Schizophrenia |
Behavioral: Cognitive remediation therapy Other: No Computerized Cognitive Skills Training |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Does Computerized Cognitive Skills Training Change Brain Activation Patterns in Schizophrenia? |
Estimated Enrollment: | 26 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Group: Active Comparator |
Behavioral: Cognitive remediation therapy
36 sessions of computerized cognitive skills training over a 12 week duration.
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Control Group: No Intervention |
Other: No Computerized Cognitive Skills Training
Patients attend 'treatment-as-usual' mall program sessions, with similar clinician exposure time as the active group.
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Abnormalities in the domains of attention, working memory (WM) and information processing are important features of schizophrenia. There is growing literature that cognitive remediation therapy (CRT) can produce modest improvements in cognitive functioning in schizophrenia, suggesting that systematic efforts at improving cognitive functioning are feasible. Cognitive improvement after CRT may correlate with changes in brain activation patterns in specific areas.
After screening, patients are randomized to a 12 week trial of CRT using COGPACK (Marker Software), or to a 12-week control condition. All patients attend 3 weekly 1-hour laboratory sessions, with 1 discussion session per week.
Patients continue their antipsychotic treatment with a typical or atypical antipsychotic during the CRT and 4 weeks prior to enrollment in the study (Phase A). Following Phase A they receive baseline evaluations, including an cognitive activation task (N-back visual-letter task) while being scanned for fMRI , MATRICS neuropsychological test battery, and psychiatric, social functioning, and symptoms assessment.
Patients then enter Phase B with randomization to control or CRT for 12 weeks (36 laboratory sessions). Upon successful completion of 36 sessions, endpoint evaluations include an N-back task while fMRI scan, MATRICS, psychiatric, and social functional assessments.
All baseline and endpoint fMRI scans are conducted at the Center for Advanced Brain Imaging (CABI) at Nathan Kline Institute for Psychiatric Research.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anzalee Khan, MS | marcatt@omh.state.ny.us | |
Contact: Sashank Kaushik, MD | marcskk@omh.state.ny.us |
United States, New York | |
Manhattan Psychiatric Center | Recruiting |
New York, New York, United States, 10035 | |
Contact: Theresa Abad, RN 646-672-6177 manrtla@omh.state.ny.us |
Principal Investigator: | Saurabh Kaushik, MD | Manhattan Psychaitric Center |
Study Chair: | Jean-Pierre Lindenmayer, MD | Manhattan Psychiatric Center |
Study Chair: | Susan McGurk, PhD | Dartmouth College, Hanover |
Study Chair: | Craig A. Branch, PhD | Center for Advanced Brain Imaging, NKI |
Responsible Party: | Manhattan Psychiatric Center ( Saurabh Kaushik ) |
Study ID Numbers: | 05I/C52 |
Study First Received: | February 2, 2007 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00431223 |
Health Authority: | United States: Institutional Review Board |
fMRI working memory schizophrenia treatment refractory |
cognitive skills training dorsolateral prefrontal cortex cognitive remediation treatment refractory schizophrenia of > 5 years duration |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |