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ERG Components in Schizophrenia and Bipolar Disorder Type I

NCT03788811 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-08-22

No results posted yet for this study

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

Interventions

DEVICE

ERG assessment (RSPA)

Processing and analysis of retinal signals

Sponsors & Collaborators

  • diaMentis Inc.

    lead INDUSTRY

Principal Investigators

  • Claude Hariton, PhD, DSc · diaMentis Inc.

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03788811 on ClinicalTrials.gov