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Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia (CRIS)
This study is currently recruiting participants.
Study NCT00312962   Information provided by National Institute of Mental Health (NIMH)
First Received: April 7, 2006   Last Updated: March 10, 2009   History of Changes

April 7, 2006
March 10, 2009
April 2004
September 2009   (final data collection date for primary outcome measure)
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 ]
  • Measured at Week 24 and at 6-month follow-up: Cognitive performance
  • Symptom profile
  • Quality of life
  • Social cue recognition
Complete list of historical versions of study NCT00312962 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia
Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia

This study will determine the effectiveness of reward-intensive, computer-based targeted cognitive training in improving neurocognitive deficits in people with schizophrenia.

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Schizophrenia
  • Behavioral: Targeted cognitive training (TCT)
  • Behavioral: Computer games
  • Active Comparator: Participants will use commercially available computer games
  • Experimental: Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact: Alex Genevsky 415-221-4810 ext 5488 alex.genevsky@va.gov
United States
 
NCT00312962
Sophia Vinogradov, MD, University of California, San Francisco / San Francisco VA Medical Center
R01 MH068725, DATR A2-AISZ
National Institute of Mental Health (NIMH)
 
Principal Investigator: Sophia Vinogradov, MD UCSF, SFVAMC, NCIRE
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP