Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING

ERG Components in Schizophrenia and Bipolar Disorder Type I

NCT03788811 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DEVICE ERG assessment (RSPA)

Study Locations (19)

California

  • Collaborative Neuroscience Research LLC — Garden Grove
  • Synergy San Diego — Lemon Grove
  • Collaborative Neuroscience Research LLC — Torrance

New York

  • The Zucker Hillside Hospital — Glen Oaks
  • University of Rochester Medical Center — Rochester
  • Richmond Behavioral Associates — Staten Island

Victoria

  • Monash Medical Centre — Clayton
  • Barwon Health University Hospital — Geelong
  • Albert Road Clinic — Melbourne

Quebec

  • Institut Universitaire en Santé Mentale de Montréal — Montreal
  • Douglas Mental Health University Institute — Montreal
  • CISSS-CA Hôpital de Saint-Georges — Saint-Georges

Florida

  • Segal trials West Broward Outpatient Site — Lauderhill
  • Segal Trials Miami Lakes Medical Research — Miami Lakes

Ontario

  • Queen's University — Kingston
  • Centre for Addiction and Mental Health (CAMH) — Toronto

Massachusetts

  • McLean Hospital — Belmont

New Jersey

  • Rutgers University Behavioral HealthCare — Piscataway

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2018-07-05
Est. Completion 2026-12-31

Sponsor

diaMentis

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03788811

The ClinicalTrials.gov registry entry for NCT03788811 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is diaMentis, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention — of which ERG assessment (RSPA) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03788811 reports 19 study locations spanning 9 distinct geographic areas — top geographies include California, New York, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03788811 about?

NCT03788811 is a clinical study titled "ERG Components in Schizophrenia and Bipolar Disorder Type I". 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 th...

What is the current status of trial NCT03788811?

This trial is currently active not recruiting. The enrollment target is 300 participants. The study started on 2018-07-05. Estimated completion is 2026-12-31.

What conditions does trial NCT03788811 study?

This clinical trial studies the following conditions: Schizophrenia, Bipolar I Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03788811?

The interventions under investigation include: ERG assessment (RSPA) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03788811?

This trial is sponsored by diaMentis, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03788811 being conducted?

This trial has 19 study locations across California, Florida, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial