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ERG Components in Schizophrenia and Bipolar Disorder Type I
Sponsor: diaMentis Inc.
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
Conditions
Interventions
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