- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06911931
Visual Perception in Schizophrenia
November 10, 2025 updated by: Edmund Lalor, University of Rochester
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).
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Edmund Lalor, PhD
- Phone Number: 585-275-3077
- Email: Edmund_Lalor@URMC.Rochester.edu
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- Recruiting
- University of Rochester
-
Contact:
- Edmund Lalor, PhD
- Phone Number: 585-3533824
- Email: Edmund_Lalor@urmc.rochester.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All participants
|
Non-invasive scalp EEG measure of early cortical visual processing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
mean amplitude of EEG visual response
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2025
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Study Registration Dates
First Submitted
March 28, 2025
First Submitted That Met QC Criteria
March 28, 2025
First Posted (Actual)
April 4, 2025
Study Record Updates
Last Update Posted (Actual)
November 12, 2025
Last Update Submitted That Met QC Criteria
November 10, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00007500
- R21MH140245 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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