Schizophrenia DisordersNCT06911931
Visual Perception in Schizophrenia
A study testing EEG measure of visual processing in people with Schizophrenia Disorders and Bipolar Disorder, run by University of Rochester at 1 site in United States.
Trial summary
This study aims to identify novel markers of psychosis using electroencephalography (EEG). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Disorders, Bipolar Disorder, Schizo Affective Disorder
- What is being tested?
- EEG measure of visual processing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Subjects
- Aged 18-65
- 20/32 visual acuity or better (using in-house optical correction, if necessary)
- An ability to speak English well enough to complete study assessments and to consent to the study
- Subjects with Schizophrenia-Spectrum Disorder
- Meets DSM-5 diagnostic criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder as confirmed by the Structured Interview for DSM-5 (SCID-5).
- Subjects with Bipolar Disorder
- Meets DSM-5 diagnostic criteria for bipolar disorder (type I, II, or unspecified) as confirmed by the Structured Interview for DSM-5 (SCID-5).
Who cannot join
- All subjects
- Presence of characteristics that could impair one's ability to comprehend the nature of the study, provide informed consent, or understand the assessment questions, including the following:
- Subject cannot read and understand the instructions well enough to complete the tasks or cannot provide informed consent.
- Intellectual impairment (WRAT-5 score < 70) (at the discretion of experimenter);
- Actively intoxicated, as shown via patient self-report or staff report;
- Substance use disorder in the past 3 months;
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- Subject considered high risk for suicidal acts (i.e., active suicidal ideation as determined by clinical interview OR any suicide attempt in 30 days prior to screening);
- Subject violence (involving severe/lethal means or violence occurring in prior 6 months) or extreme agitation.
- Being in a current manic state
- Head injury with loss of consciousness greater than 10 minutes (at the discretion of the experimenter).
- Subject has had electroconvulsive therapy (ECT) in the past 8 weeks;
- Diagnosed with a neurological condition (tumor, stroke, brain injury) or neurological disorder, including seizure disorders. Diagnosed with pervasive developmental disorder (phone screen or medical records)
- Lazy eye or squint or other known ocular pathology
- Healthy Control Subjects
- Any lifetime psychotic disorder or history of psychiatric hospitalization (self disclosure);
- Daily antidepressant, mood stabilizer or antipsychotic medication use in the last 6 months, or benzodiazepine use during the prior 2 days (self-disclosure); iii. First-degree relative(s) with a schizophrenia spectrum disorder (based on subject self-report) or bipolar disorder.
- Case-match Control Non-ill Subjects
- Any lifetime psychotic disorder (as assessed by SCID/or SSD);
- Recurrent depressive episodes or being in a current depressive episode (as assessed by SCID/or SSD)
- Persistent threshold psychotic symptoms
- History of psychiatric hospitalization;
- Daily antidepressant, mood stabilizer or antipsychotic medication use in the last 6 months, or benzodiazepine use during the prior 2 days
- First-degree relative(s) with a schizophrenia spectrum disorder (based on subject self-report) or bipolar disorder.
- Bipolar Subjects
- Persistent threshold psychotic symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Edmund Lalor, PhD, 585-3533824, Edmund_Lalor@urmc.rochester.edu
About this study
Official title: Visual Perception in Schizophrenia: Assessing Predictive Processing in the Earliest Stages of the Visual Cortical Hierarchy
This study aims to identify novel markers of psychosis using electroencephalography (EEG).
- Being tested
- EEG measure of visual processing
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG measure of visual processingOther
Non-invasive scalp EEG measure of early cortical visual processing.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Not described Receives: Other: EEG measure of visual processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean amplitude of EEG visual response
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start3 Nov 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Edmund Lalor, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911931
- Sponsor's protocol ID
- STUDY00007500
- Other IDs
- R21MH140245
- Status last verified
- Nov 2025
- First submitted
- 28 Mar 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Perception in Schizophrenia: Assessing Predictive Processing in the Earliest Stages of the Visual Cortical Hierarchy
- ClinicalTrials.gov ID
- NCT06911931
- Acronym / sponsor ID
- STUDY00007500
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- 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.
This study aims to identify novel markers of psychosis using electroencephalography (EEG).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: EEG measure of visual processing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All Subjects
- Aged 18-65
- 20/32 visual acuity or better (using in-house optical correction, if necessary)
- An ability to speak English well enough to complete study assessments and to consent to the study
- Subjects with Schizophrenia-Spectrum Disorder
Key exclusion criteria (25 listed)
- All subjects
- Presence of characteristics that could impair one's ability to comprehend the nature of the study, provide informed consent, or understand the assessment questions, including the following:
- Healthy Control Subjects
- Any lifetime psychotic disorder or history of psychiatric hospitalization (self disclosure);
- Daily antidepressant, mood stabilizer or antipsychotic medication use in the last 6 months, or benzodiazepine use during the prior 2 days (self-disclosure); iii. First-degree relative(s) with a schizophrenia spectrum disorder (based on subject self-report) or bipolar disorder.
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 |
|---|---|---|
| EEG measure of visual processingNon-invasive scalp EEG measure of early cortical visual processing. | Other | All participants |
Primary outcome
mean amplitude of EEG visual response
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG measure of visual processing in people with Schizophrenia Disorders and Bipolar Disorder, run by University of Rochester 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 8 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 12 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edmund Lalor, PhD (585-275-3077, Edmund_Lalor@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean amplitude of EEG visual response (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2025.