SchizophreniaPhase 1/2NCT00694889
Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
A Phase 1/2 study testing Neuroadaptive cognitive training and Computer games in people with Schizophrenia, run by University of California, San Francisco at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Neuroadaptive cognitive training and Computer games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Feb 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Any neurological disorder
- History of psychoactive substance abuse in the past 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Davis
Sacramento, California, 95817
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the detailed description
Participation in this study will last approximately 12 months and will involve individuals with recent-onset schizophrenia. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The 8 weeks of treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard commercially available games, with no targeted response.
Participants will repeat baseline assessments after the computer training and Month 6 of follow-up. The EEG and MRI will be repeated only at post training assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants in the control condition will be offered an opportunity to complete an additional 8 weeks of computer training with different modules.
- Conditions
- Schizophrenia
- Being tested
- Neuroadaptive cognitive training, Computer games
- Keywords
- Psychosis, First Episode, Schizophrenia, Cognitive Remediation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroadaptive cognitive trainingBehavioural
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.
Computer gamesBehavioural
The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will use commercially available computer games. Receives: Behavioral: Computer games |
| 2 | Experimental | Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation. Receives: Behavioral: Neuroadaptive cognitive training |
| 3 | Active comparator | Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation. Receives: Behavioral: Neuroadaptive cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performance, as measured by a neuropsychological battery
Measured: Measured at Baseline, Week 8, and 6 Month Follow-Up
Secondary outcomes (1)
Symptom profile, as measured by clinical interviews
Measured: Measured at Baseline, Week 8, and 6 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startAug 2007
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Sophia Vinogradov, MD, Principal investigator, University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research InstituteRachel Loewy, PhD, Study director, University of California, San FranciscoCameron Carter, MD, Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694889
- Sponsor's protocol ID
- 06TAF-972
- Status last verified
- May 2016
- First submitted
- 9 Jun 2008
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33539561Puig 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 32141724Roach 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.
PubMed 30599145Biagianti 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.
PubMed 28845238Biagianti 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.
PubMed 27617637Panizzutti 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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
- ClinicalTrials.gov ID
- NCT00694889
- Acronym / sponsor ID
- 06TAF-972
- Conditions
- Schizophrenia
- Keywords
- Psychosis, First Episode, Schizophrenia, Cognitive Remediation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Aug 2007
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participation in this study will last approximately 12 months and will involve individuals with recent-onset schizophrenia. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The 8 weeks of treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard commercially available games, with no targeted response.
Participants will repeat baseline assessments after the computer training and Month 6 of follow-up. The EEG and MRI will be repeated only at post training assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants in the control condition will be offered an opportunity to complete an additional 8 weeks of computer training with different modules.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Computer gamesParticipants will use commercially available computer games. |
| 2 | Experimental | Behavioral: Neuroadaptive cognitive trainingParticipants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation. |
| 3 | Active comparator | Behavioral: Neuroadaptive cognitive trainingHealthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Any neurological disorder
- History of psychoactive substance abuse in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroadaptive cognitive trainingNeuroadaptive 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. | Behavioural | 2, 3 |
| Computer gamesThe control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks. | Behavioural | 1 |
Primary outcome
Cognitive Performance, as measured by a neuropsychological battery
Time frame: Measured at Baseline, Week 8, and 6 Month Follow-Up
1 secondary outcome
Symptom profile, as measured by clinical interviews
Time frame: Measured at Baseline, Week 8, and 6 Month Follow-Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 33539561Roberts 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.
- Derived from this study: PubMed 32141724Puig 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.
- Derived from this study: PubMed 30599145Roach 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.
- Derived from this study: PubMed 28845238Biagianti 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.
- Derived from this study: PubMed 27617637Biagianti 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.
- Derived from this study: PubMed 22992330Panizzutti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Vinogradov, MD principal investigator
University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute
Rachel Loewy, PhD study director
University of California, San Francisco
Cameron Carter, MD study director
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neuroadaptive cognitive training and Computer games in people with Schizophrenia, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Performance, as measured by a neuropsychological battery (time frame: Measured at Baseline, Week 8, and 6 Month Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00694889, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.