ERG Components in Schizophrenia and Bipolar Disorder Type I

NCT03788811 | Active Not Recruiting FDA Device

• 1 other identifier: dM/CL-01
• Study Type: observational
• Target: 300
• Locations: 3 countries
• Sites: 19

Brief 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.

Conditions

Schizophrenia; Bipolar I Disorder

Keywords

Retinal Signal; Schizophrenia; Bipolar I Disorder; Support to diagnostic; ERG; Mental Disorder

Outcome Measures

Primary Outcomes (3)

• Differences in ERG components vs control ERG with full-field ERG stimulation conditions.

  ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 100 msec post stimulation.

  Three ERG assessments within 6 weeks.

• Differences in ERG components vs control ERG with Photopic Negative Response (PhNR) ERG stimulation conditions.

  ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 250 msec post stimulation.

  Three ERG assessments within 6 weeks.

• Differences in ERG components vs control ERG with On-Off ERG stimulation conditions.

  ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 300 msec post stimulation.

  Three ERG assessments within 6 weeks.

Study Arms (3)

Control subjects

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.

Device: ERG assessment (RSPA)

Patients with schizophrenia (SZ)

Patient with a diagnosis of schizophrenia for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT).

Device: ERG assessment (RSPA)

Patients with bipolar disorder Type I (BP1)

Patient with a diagnosis of bipolar disorder Type 1 for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT).

Device: ERG assessment (RSPA)

Interventions

ERG assessment (RSPA) DEVICE

Processing and analysis of retinal signals

Control subjects; Patients with bipolar disorder Type I (BP1); Patients with schizophrenia (SZ)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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); and 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 qualify if:

• Able to give written informed consent;
• 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.

Sponsors & Collaborators

• diaMentis Inc.: lead

Study Sites (19)

Collaborative Neuroscience Research LLC

Garden Grove, California, 92845, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Collaborative Neuroscience Research LLC

Torrance, California, 90502, United States

Location

Segal trials West Broward Outpatient Site

Lauderhill, Florida, 33319, United States

Location

Segal Trials Miami Lakes Medical Research

Miami Lakes, Florida, 33016, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Rutgers University Behavioral HealthCare

Piscataway, New Jersey, 08854, United States

Location

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

University Hills Clinical Research

Irving, Texas, 75062, United States

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Barwon Health University Hospital

Geelong, Victoria, 3220, Australia

Location

Albert Road Clinic

Melbourne, Victoria, 3004, Australia

Location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, M6J 1H4, Canada

Location

Institut Universitaire en Santé Mentale de Montréal

Montreal, Quebec, H1N 3M5, Canada

Location

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

CISSS-CA Hôpital de Saint-Georges

Saint-Georges, Quebec, G5Y 4T8, Canada

Location

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Claude Hariton, PhD, DSc

  diaMentis Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 28, 2018
• Study Start: July 5, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); AU (3); CA (5)