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CompletedNCT00312962CRISUpdated Mar 11, 2014

Effectiveness of Targeted Cognitive Training for Neurological Deficits in People With Schizophrenia

A Phase 1/2 interventional study of Targeted cognitive training (TCT) and Computer games in Schizophrenia, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-11.

Sponsored by University of California, San Francisco · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Schizophrenia

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Keywords

  • Schizoaffective Disorder
  • Cognitive Remediation
  • fMRI
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 80 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • History of substance abuse within 6 months prior to study entry
  • Neurological disorder
  • Any metal in the body, or claustrophobia
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    1

    Participants will use commercially available computer games

    Behavioral: Computer games

  • Experimental
    2

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

    Behavioral: Targeted cognitive training (TCT)

Interventions

  • BehavioralTargeted 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.

  • BehavioralComputer 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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What researchers measure

Primary outcomes

  1. Cognitive performance as measured by a neuropsychological battery

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

Secondary outcomes

  1. Symptom profile as measured by clinical interviews

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

  2. Quality of life as measured by clinical interviews

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

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Study locations

1 site
  • San Francisco Department of Veterans Affairs Medical Center
    San Francisco, California 94121, United States
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References and documents

Publications

  • Puig O, Fisher M, Loewy R, Miley K, Ramsay IS, Carter CS, Ragland JD, Niendam T, Vinogradov S. Early- Versus Adult-Onset Schizophrenia as a Predictor of Response to Neuroscience-Informed Cognitive Training. J Clin Psychiatry. 2020 Mar 3;81(2):18m12369. doi: 10.4088/JCP.18m12369. PubMed 32141724 ↗
  • Panizzutti R, Hamilton SP, Vinogradov S. Genetic correlate of cognitive training response in schizophrenia. Neuropharmacology. 2013 Jan;64(1):264-7. doi: 10.1016/j.neuropharm.2012.07.048. Epub 2012 Aug 7. PubMed 22992330 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00312962
Lead sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Apr 11, 2006
Start date
Apr 2004
Primary completion
Mar 2012
Completion
Mar 2013
Last update
Mar 11, 2014

Study contacts

Sophia Vinogradov, MD
principal investigator · UCSF, SFVAMC, NCIRE

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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