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.
- Diseases
- Schizophrenia, Bipolar disorder
- 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
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Barwon Health University Hospital Coordinator of this site? Confirm its status | Geelong | Australia | Unknown status |
| Albert Road Clinic Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Queen's University Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Douglas Mental Health University Institute Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Institut universitaire en santé mentale de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CISSS-CA Hôpital de Saint-Georges Coordinator of this site? Confirm its status | Saint-Georges | Canada | Unknown status |
| Centre for Addiction and Mental Health (CAMH) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Unknown status |
| Collaborative NeuroScience Research , LLC Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| The Zucker Hillside Hospital Coordinator of this site? Confirm its status | Glen Oaks | United States | Unknown status |
| University Hills Clinical Research Coordinator of this site? Confirm its status | Irving | United States | Unknown status |
| Segal Trials - West Broward Outpatient Site Coordinator of this site? Confirm its status | Lauderhill | United States | Unknown status |
| Synergy San Diego Coordinator of this site? Confirm its status | Lemon Grove | United States | Unknown status |
| Segal Trials Miami Lakes Medical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Rutgers University Behavioral HealthCare Coordinator of this site? Confirm its status | Piscataway | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Richmond Behavioral Associates Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| Collaborative Neuroscience Research LLC Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.