Fact CheckerSign in

NCT03788811Active, not recruiting

ERG Components in Schizophrenia and Bipolar Disorder Type I

Assessment of ERG Components to Discriminate Between Schizophrenia and Bipolar Disorder Type I

Source: ClinicalTrials.gov · Last updated 22 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
20 Dec 2018
Start date
5 Jul 2018
Primary completion date
31 Dec 2026
Lead sponsor
diaMentis Inc.
NCT number
NCT03788811

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 5 Jul 2018 to the primary completion date, 31 Dec 2026
  • 19 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Control subjects taking antipsychotic drugs (other prescription medicines are allowed);
  • 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;

Other illness

  • Control subjects with a first-degree relative with SZ, BP, other psychotic disorder or recurrent major depressive disorder;
  • 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 person contra-indicated for an ERG test, including active corneal or conjunctival disease (e.g. pink eye or conjunctivitis), infection or a ruptured globe;
  • 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.

Other

  • Patient currently in an acute inpatient unit and not stable (i.e. experiencing an acute exacerbation of psychosis or mania);
  • 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 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Medical Centre
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Barwon Health University Hospital
Coordinator of this site? Confirm its status
GeelongAustraliaUnknown status
Albert Road Clinic
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Queen's University
Coordinator of this site? Confirm its status
KingstonCanadaUnknown status
Douglas Mental Health University Institute
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Institut universitaire en santé mentale de Montréal
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
CISSS-CA Hôpital de Saint-Georges
Coordinator of this site? Confirm its status
Saint-GeorgesCanadaUnknown status
Centre for Addiction and Mental Health (CAMH)
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
McLean Hospital
Coordinator of this site? Confirm its status
BelmontUnited StatesUnknown status
Collaborative NeuroScience Research , LLC
Coordinator of this site? Confirm its status
Garden GroveUnited StatesUnknown status
The Zucker Hillside Hospital
Coordinator of this site? Confirm its status
Glen OaksUnited StatesUnknown status
University Hills Clinical Research
Coordinator of this site? Confirm its status
IrvingUnited StatesUnknown status
Segal Trials - West Broward Outpatient Site
Coordinator of this site? Confirm its status
LauderhillUnited StatesUnknown status
Synergy San Diego
Coordinator of this site? Confirm its status
Lemon GroveUnited StatesUnknown status
Segal Trials Miami Lakes Medical Research
Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
Rutgers University Behavioral HealthCare
Coordinator of this site? Confirm its status
PiscatawayUnited StatesUnknown status
University of Rochester Medical Center
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Richmond Behavioral Associates
Coordinator of this site? Confirm its status
Staten IslandUnited StatesUnknown status
Collaborative Neuroscience Research LLC
Coordinator of this site? Confirm its status
TorranceUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.