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ACTIVE NOT RECRUITING
NCT03788811

ERG Components in Schizophrenia and Bipolar Disorder Type I

Sponsor: diaMentis Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2018-07-05

Completion Date

2026-12-31

Last Updated

2025-08-22

Healthy Volunteers

Yes

Interventions

DEVICE

ERG assessment (RSPA)

Processing and analysis of retinal signals

Locations (19)

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