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Clinical Trials in Canada / NCT03788811
Active, not recruiting Observational

ERG Components in Schizophrenia and Bipolar Disorder Type I

NCT03788811 · tracked via the Priya Life Science Canada tracker
Sponsor
diaMentis Inc
Phase
Observational
Started
2018-07-05
Last updated
2025-08-22

Condition(s) studied

SchizophreniaBipolar I Disorder

Investigational drug(s) / intervention(s)

ERG assessment (RSPA)

ERG assessment (RSPA): Processing and analysis of retinal signals

Study summary

This study will further assess ERG components obtained with different ERG devices, to be considered in a prediction model for each diagnosis. The prediction models are diaMentis proprietary software used as an ERG-based diagnostic test (classified as a Software as Medical Device, SaMD) to support the diagnosis of schizophrenia and bipolar disorder type I. They involve the processing and analysis of specific retinal biosignatures (RSPA) with the support of statistical and mathematical modelling processes e.g. machine learning and statistical learning.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Able to give written informed consent; * 18 to 50 years old; * Patient with a likely diagnosis of SZ or BPI for at least 12 months, that resulted in a diagnosis of SZ or BPI with a Structured Clinical Interview for DSM-5 (SCID-5-CT); * Control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder, recurrent mood disorder or have not met criteria for a major depression episode in the last 12 months according to DSM-V criteria. Exclusion Criteria: * Control subjects taking antipsychotic drugs (other prescription medicines are allowed); * Control subjects with a first-degree relative with SZ, BP, other psychotic disorder or recurrent major depressive disorder; * Patient currently in an acute inpatient unit and not stable (i.e. experiencing an acute exacerbation of psychosis or mania); * Diagnosed dementia, Parkinson's disease, autism or other pervasive developmental disorders or seizure disorders (such as epilepsy); * Substance use disorder within the last 6 months; * Any known diagnosis of ophthalmological abnormalities, such as diabetic retinopathy, glaucoma, change in intraocular pressure, macular degeneration, other retinal pathologies, congenital color vision deficiencies, strabismus or cataract; * Any person contra-indicated for an ERG test, including active corneal or conjunctival disease (e.g. pink eye or conjunctivitis), infection or a ruptured globe; * Subjects in recovery phase following cataract surgery or post LASIK refractive surgery or trabeculectomy or any surgical/laser intervention, suspected penetrating ocular injury, ocular prosthesis or severe photophobia; * Any person unable to or unwilling to participate in a psychiatric evaluation or ERG testing, including, in the clinical judgment of the Principal investigator, subjects with cognitive impairment that compromises their ability to participate meaningfully in a SCID-5-CT interview. * Any subject during the course of the study that is pregnant or intends on becoming pregnant and/or receives or intends to receive fertility treatments. Subjects becoming pregnant during study will be excluded.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Collaborative Neuroscience Research LLC Garden Grove California
Synergy San Diego Lemon Grove California
Collaborative Neuroscience Research LLC Torrance California
Segal trials West Broward Outpatient Site Lauderhill Florida
Segal Trials Miami Lakes Medical Research Miami Lakes Florida
McLean Hospital Belmont Massachusetts
Rutgers University Behavioral HealthCare Piscataway New Jersey
The Zucker Hillside Hospital Glen Oaks New York
University of Rochester Medical Center Rochester New York
Richmond Behavioral Associates Staten Island New York
University Hills Clinical Research Irving Texas
Monash Medical Centre Clayton Victoria
Barwon Health University Hospital Geelong Victoria
Albert Road Clinic Melbourne Victoria
Queen's University Kingston Ontario
Centre for Addiction and Mental Health (CAMH) Toronto Ontario
Institut Universitaire en Santé Mentale de Montréal Montreal Quebec
Douglas Mental Health University Institute Montreal Quebec
CISSS-CA Hôpital de Saint-Georges Saint-Georges Quebec

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03788811 on ClinicalTrials.gov ↗ ← All trials in Canada