Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
1 other identifier
interventional
144
1 country
2
Brief Summary
The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 schizophrenia
Started Aug 2007
Longer than P75 for phase_1 schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 9, 2008
CompletedFirst Posted
Study publicly available on registry
June 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMay 16, 2016
May 1, 2016
7.5 years
June 9, 2008
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive Performance, as measured by a neuropsychological battery
Measured at Baseline, Week 8, and 6 Month Follow-Up
Secondary Outcomes (1)
Symptom profile, as measured by clinical interviews
Measured at Baseline, Week 8, and 6 Month Follow-Up
Study Arms (3)
1
ACTIVE COMPARATORParticipants will use commercially available computer games.
2
EXPERIMENTALParticipants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
3
ACTIVE COMPARATORHealthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
Interventions
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.
The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
- First psychotic episode within the last 3 years
- Good general physical health
- Age between 12-35
- Is fluent and proficient in the English language
- Achieved clinical stability (e.g., outpatient status for at least 3 months before study entry; on stable doses of medication for at least 1 month before study entry
- Minors must have parental/legal guardian consent to participate
You may not qualify if:
- Any neurological disorder
- History of psychoactive substance abuse in the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California, Davis
Sacramento, California, 95817, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Related Publications (6)
Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
PMID: 33539561DERIVEDPuig 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.
PMID: 32141724DERIVEDRoach BJ, Ford JM, Biagianti B, Hamilton HK, Ramsay IS, Fisher M, Loewy R, Vinogradov S, Mathalon DH. Efference copy/corollary discharge function and targeted cognitive training in patients with schizophrenia. Int J Psychophysiol. 2019 Nov;145:91-98. doi: 10.1016/j.ijpsycho.2018.12.015. Epub 2018 Dec 29.
PMID: 30599145DERIVEDBiagianti B, Roach BJ, Fisher M, Loewy R, Ford JM, Vinogradov S, Mathalon DH. Trait aspects of auditory mismatch negativity predict response to auditory training in individuals with early illness schizophrenia. Neuropsychiatr Electrophysiol. 2017;3:2. doi: 10.1186/s40810-017-0024-9. Epub 2017 Jun 9.
PMID: 28845238DERIVEDBiagianti B, Fisher M, Neilands TB, Loewy R, Vinogradov S. Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. Neuropsychology. 2016 Nov;30(8):998-1008. doi: 10.1037/neu0000311. Epub 2016 Sep 12.
PMID: 27617637DERIVEDPanizzutti 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.
PMID: 22992330DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophia Vinogradov, MD
University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute
- STUDY DIRECTOR
Rachel Loewy, PhD
University of California, San Francisco
- STUDY DIRECTOR
Cameron Carter, MD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2008
First Posted
June 11, 2008
Study Start
August 1, 2007
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
May 16, 2016
Record last verified: 2016-05