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Recruiting NCT06911931

Visual Perception in Schizophrenia

No phase Interventional Schizophrenia Disorders Bipolar Disorder Schizo Affective Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EEG measure of visual processing.
Who it may be relevant to
Registry conditions: Schizophrenia Disorders, Bipolar Disorder, Schizo Affective Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Visual Perception in Schizophrenia: Assessing Predictive Processing in the Earliest Stages of the Visual Cortical Hierarchy

Overview

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

Interventions

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

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Rochester — Rochester

Identifiers

NCT: NCT06911931 · STUDY00007500 · R21MH140245

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗