Clinical trial NCT06911931: Visual Perception in Schizophrenia
Official title: Visual Perception in Schizophrenia: Assessing Predictive Processing in the Earliest Stages of the Visual Cortical Hierarchy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia Disorders
Bipolar Disorder
Schizo Affective Disorder
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: mean amplitude of EEG visual response
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: