SchizophreniaNCT02337439
Perceptual Deficits in Schizophrenia
A study testing Sensory Information Processing Training in people with Schizophrenia and Schizoaffective Disorder, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
In this study, participants with schizophrenia and schizoaffective are given computer exercises to complete. The goals of the study are to determine whether: 1) any of the computer exercises can improve information processing problems in schizophrenia, 2) improvements in information processing are related to other… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Sensory Information Processing Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2018
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- schizophrenia or schizoaffective disorder
- English speaking and reading
Who cannot join
- current substance abuse
- visual impairment
- neurological conditions
- current enrollment in another research study
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06511
About this study
Official title: Cognitive Remediation for Perceptual Deficits in Schizophrenia
In this study, participants with schizophrenia and schizoaffective are given computer exercises to complete. The goals of the study are to determine whether: 1) any of the computer exercises can improve information processing problems in schizophrenia, 2) improvements in information processing are related to other cognitive improvements, and 3) there are changes in brain activity associated with using the computer exercises.
The study will involve clinical interviews, cognitive tests, and frequent computerized cognitive training over the course of 2 months. Some participants will also have electroencephalography, a non-invasive test that measures brain activity, to determine whether there are changes in brain activity with the computer training.
Read the detailed description
Schizophrenia is a disabling neurodevelopmental illness, affecting nearly 1% of the population. The disability of schizophrenia is due in large part to the effects of the illness on cognitive faculties. Current medications for schizophrenia do not generally improve cognition, so a major contribution to disability remains undertreated. Computerized cognitive remediation programs, which produce activity-dependent recruitment of neural resources to specifically enhance under-functioning brain systems, have been effective at improving both cognition and community functioning in patients with schizophrenia, but the effects are still modest. Our preliminary work has suggested that our training is associated with improvements in visual memory, though visual memory has been a cognitive area more refractory to cognitive training.
In this study, participants with schizophrenia or schizoaffective disorder will be randomized to receive different computer exercises to help determine whether computer exercises can improve memory in schizophrenia, and whether the cognitive training is associated with changes in neural activity.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Sensory Information Processing Training, Active Control Training
- 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.
Sensory Information Processing TrainingBehavioural
Computer exercises requiring identification of visual stimuli on computer screen and response with keyboard
Active Control TrainingBehavioural
Commercially available educational software
| Study group | Role | What they receive |
|---|---|---|
| Sensory Information Processing Training | Experimental | Computerized training designed to improve sensory processing Receives: Behavioral: Sensory Information Processing Training |
| Active Control Training | Active comparator | Commercially available computer exercises that were not designed specifically to improve sensory information processing. Receives: Behavioral: Active Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive test performance
Neuropsychological testing
Measured: up to 6 months
Secondary outcomes (2)
Psychiatric symptoms
Clinical interviews and ratings
Measured: up to 6 months
Social Functioning
Clinical rating scales
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337439
- Sponsor's protocol ID
- V1CDA2013-24
- Other IDs
- 01856
- Status last verified
- Nov 2017
- First submitted
- 8 Jan 2015
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Tandon R, Keshavan MS, Nasrallah HA. Schizophrenia, "just the facts" what we know in 2008. 2. Epidemiology and etiology. Schizophr Res. 2008 Jul;102(1-3):1-18. doi: 10.1016/j.schres.2008.04.011. Epub 2008 Jun 2.
PubMed 18514488Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
PubMed 8610818Carpenter WT, Buchanan RW. Lessons to take home from CATIE. Psychiatr Serv. 2008 May;59(5):523-5. doi: 10.1176/ps.2008.59.5.523.
PubMed 18451009McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906.
PubMed 18056233Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.
PubMed 21406461Surti TS, Wexler BE. A pilot and feasibility study of computer-based training for visual processing deficits in schizophrenia. Schizophr Res. 2012 Dec;142(1-3):248-9. doi: 10.1016/j.schres.2012.09.013. Epub 2012 Oct 6. No abstract available.
PubMed 23043873
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation for Perceptual Deficits in Schizophrenia
- ClinicalTrials.gov ID
- NCT02337439
- Acronym / sponsor ID
- V1CDA2013-24
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- Aug 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Jan 2015 (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.
In this study, participants with schizophrenia and schizoaffective are given computer exercises to complete. The goals of the study are to determine whether: 1) any of the computer exercises can improve information processing problems in schizophrenia, 2) improvements in information processing are related to other cognitive improvements, and 3) there are changes in brain activity associated with using the computer exercises.
The study will involve clinical interviews, cognitive tests, and frequent computerized cognitive training over the course of 2 months. Some participants will also have electroencephalography, a non-invasive test that measures brain activity, to determine whether there are changes in brain activity with the computer training.
Detailed description
Schizophrenia is a disabling neurodevelopmental illness, affecting nearly 1% of the population. The disability of schizophrenia is due in large part to the effects of the illness on cognitive faculties. Current medications for schizophrenia do not generally improve cognition, so a major contribution to disability remains undertreated. Computerized cognitive remediation programs, which produce activity-dependent recruitment of neural resources to specifically enhance under-functioning brain systems, have been effective at improving both cognition and community functioning in patients with schizophrenia, but the effects are still modest. Our preliminary work has suggested that our training is associated with improvements in visual memory, though visual memory has been a cognitive area more refractory to cognitive training.
In this study, participants with schizophrenia or schizoaffective disorder will be randomized to receive different computer exercises to help determine whether computer exercises can improve memory in schizophrenia, and whether the cognitive training is associated with changes in neural activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory Information Processing Training | Experimental | Behavioral: Sensory Information Processing TrainingComputerized training designed to improve sensory processing |
| Active Control Training | Active comparator | Behavioral: Active Control TrainingCommercially available computer exercises that were not designed specifically to improve sensory information processing. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- schizophrenia or schizoaffective disorder
- English speaking and reading
Key exclusion criteria (4 listed)
- current substance abuse
- visual impairment
- neurological conditions
- current enrollment in another research study
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 |
|---|---|---|
| Sensory Information Processing TrainingComputer exercises requiring identification of visual stimuli on computer screen and response with keyboard | Behavioural | Sensory Information Processing Training |
| Active Control TrainingCommercially available educational software | Behavioural | Active Control Training |
Primary outcome
Cognitive test performance
Time frame: up to 6 months
Neuropsychological testing
2 secondary outcomes
Psychiatric symptoms
Time frame: up to 6 months
Social Functioning
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 18514488Tandon R, Keshavan MS, Nasrallah HA. Schizophrenia, "just the facts" what we know in 2008. 2. Epidemiology and etiology. Schizophr Res. 2008 Jul;102(1-3):1-18. doi: 10.1016/j.schres.2008.04.011. Epub 2008 Jun 2.
- Background: PubMed 8610818Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
- Background: PubMed 18451009Carpenter WT, Buchanan RW. Lessons to take home from CATIE. Psychiatr Serv. 2008 May;59(5):523-5. doi: 10.1176/ps.2008.59.5.523.
- Background: PubMed 18056233McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906.
- Background: PubMed 21406461Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.
- Background: PubMed 23043873Surti TS, Wexler BE. A pilot and feasibility study of computer-based training for visual processing deficits in schizophrenia. Schizophr Res. 2012 Dec;142(1-3):248-9. doi: 10.1016/j.schres.2012.09.013. Epub 2012 Oct 6. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Information Processing Training in people with Schizophrenia and Schizoaffective Disorder, run by VA Connecticut Healthcare System at 1 site 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
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 test performance (time frame: up to 6 months). 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 NCT02337439, 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 7 Nov 2017.