NCT06911931

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Nov 2025Jan 2027

First Submitted

Initial submission to the registry

March 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

November 3, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

March 28, 2025

Last Update Submit

November 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • mean amplitude of EEG visual response

    Day 1

Study Arms (1)

All participants

EXPERIMENTAL
Other: EEG measure of visual processing

Interventions

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

All participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All Subjects
  • Aged 18-65
  • /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).

You may not qualify if:

  • 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);
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

SchizophreniaBipolar DisorderPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 4, 2025

Study Start

November 3, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Locations