Recruiting

Observational Study

Sponsor:

University of Rochester

Code:

NCT06911931

Conditions

Schizophrenia Disorders

Bipolar Disorder

Schizo Affective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

EEG measure of visual processing

Study Details

Brief summary:

This study aims to identify novel markers of psychosis using electroencephalography (EEG).

Conditions

Schizophrenia Disorders

Bipolar Disorder

Schizo Affective Disorder

Study ID

NCT06911931

Start date

Nov 3, 2025

Status verified date

Nov, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

84 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: All participants

Interventions

EEG measure of visual processing

Non-invasive scalp EEG measure of early cortical visual processing.

Primary outcome measure

  • mean amplitude of EEG visual response [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

More Information

Sponsor

University of Rochester

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-11-12.