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Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia (CRIS)
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), October 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00312962
  Purpose

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
Schizophrenia
Behavioral: Targeted cognitive training (TCT)
Behavioral: Computer games
Phase I
Phase II

MedlinePlus related topics: Schizophrenia
Drug Information available for: Amphetamine Methamphetamine
U.S. FDA Resources
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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Cognitive performance as measured by a neuropsychological battery [ Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom profile as measured by clinical interviews [ Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up ] [ Designated as safety issue: No ]
  • Quality of life as measured by clinical interviews [ Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2004
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Participants will use commercially available computer games
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.
2: Experimental
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Good general health
  • First language is English
  • Clinically stable (i.e., no inpatient hospital stays for 3 months prior to study entry; on stable doses of medication)

Exclusion Criteria:

  • History of substance abuse within 6 months prior to study entry
  • Neurological disorder
  • Any metal in the body, or claustrophobia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312962

Contacts
Contact: Alex Genevsky 415-221-4810 ext 5488 alex.genevsky@va.gov

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: Sophia Vinogradov, MD UCSF, SFVAMC, NCIRE
  More Information

Responsible Party: University of California, San Francisco / San Francisco VA Medical Center ( Sophia Vinogradov, MD )
Study ID Numbers: R01 MH68725, DATR A2-AISZ
Study First Received: April 7, 2006
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00312962  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Schizoaffective Disorder
Cognitive Remediation
fMRI

Study placed in the following topic categories:
Schizophrenia
Methamphetamine
Mental Disorders
Amphetamine
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 30, 2009