ERG Components in Schizophrenia and Bipolar Disorder Type I

Running, not enrolling

Conditions studied: Schizophrenia, Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT03788811

Run by

diaMentis Inc.

People needed

300

Starts

2018-07-05

Expected to finish

2026-12-31

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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