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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: | NCT00312962 |
This study will determine the effectiveness of reward-intensive, computer-based targeted cognitive training in improving neurocognitive deficits in people with schizophrenia.
Condition | Intervention | Phase |
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Schizophrenia |
Behavioral: Targeted cognitive training (TCT) Behavioral: Computer games |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia |
Estimated Enrollment: | 80 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will use commercially available computer games
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Behavioral: Computer games
The control treatment involves commercially available computer games that participants practice 1 hour per day, 5 days per week, for 20 weeks.
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2: Experimental
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation
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Behavioral: Targeted cognitive training (TCT)
TCT includes cognitive remediation exercises that participants practice 1 hour per day, 5 days per week, for 20 weeks. TCT exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuo-spatial targets.
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Schizophrenia is a chronic brain disorder that causes severe disability. It is characterized by psychotic symptoms, including hallucinations and delusions. Neurocognitive deficits, such as impaired neurocognitive processing efficiency, also affect people with schizophrenia. This deficiency in the speed and accuracy with which the brain perceives and responds to targets causes scrambled messages to be transmitted in the brain, thereby affecting executive control and memory. Medications are available that effectively treat the psychotic symptoms. The neurocognitive deficits, however, do not subside with medication treatment, and are responsible for the failure to improve the e their psychosocial functioning of people with schizophrenia, even after their psychotic symptoms have gone into remission. The targeted cognitive training (TCT) exercises in this study are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuo-spatial targets. This study will determine the effectiveness of reward-intensive, computer-based TCT in improving neurocognitive deficits in people with schizophrenia.
Participants in this double-blind study will be paired according to IQ and baseline symptom severity. One member of each pair will be randomly assigned to training exercises that use TCT. The other will be assigned to a control intervention, which will involve commercially available computer games. All participants will complete exercises with their assigned intervention for 1 hour per day, 5 days per week, until 90 hours of training has been accumulated. Neuroimaging will be performed on a subgroup of participants to examine changes in brain activation patterns in response to the cognitive training. Upon study completion and at the 6-month follow up visit, participants will be assessed for improvement in the following areas: cognitive performance; symptom profile; quality of life; and social cue recognition.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alex Genevsky | 415-221-4810 ext 5488 | alex.genevsky@va.gov |
United States, California | |
San Francisco Department of Veterans Affairs Medical Center | Recruiting |
San Francisco, California, United States, 94121 | |
Contact: Christine S. Holland, BA 415-221-4810 ext 5488 christine.holland@med.va.gov | |
Contact: Laura Rymland, BA 415-221-4810 ext 3077 laura.rymland@va.gov | |
Principal Investigator: Sophia Vinogradov, MD |
Principal Investigator: | Sophia Vinogradov, MD | UCSF, SFVAMC, NCIRE |
Responsible Party: | University of California, San Francisco / San Francisco VA Medical Center ( Sophia Vinogradov, MD ) |
Study ID Numbers: | R01 MH068725, DATR A2-AISZ |
Study First Received: | April 7, 2006 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00312962 History of Changes |
Health Authority: | United States: Federal Government |
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