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Clinical Trials/NCT00312962
NCT00312962CompletedPhase 1

Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia

University of California, San Francisco1 site in 1 country80 target enrollmentStarted: April 1, 2004Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Cognitive performance as measured by a neuropsychological battery

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

1

Active Comparator

Participants will use commercially available computer games

Intervention: Computer games (Behavioral)

2

Experimental

Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation

Intervention: Targeted cognitive training (TCT) (Behavioral)

Outcomes

Primary Outcomes

Cognitive performance as measured by a neuropsychological battery

Time Frame: Measured at Weeks 8, 14, and 8 and Month 6 follow-up

Secondary Outcomes

  • Symptom profile as measured by clinical interviews(Measured at Weeks 8, 14, and 8 and Month 6 follow-up)
  • Quality of life as measured by clinical interviews(Measured at Weeks 8, 14, and 8 and Month 6 follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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