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NCT03788811 · ClinicalTrials.gov registry record
ERG Components in Schizophrenia and Bipolar Disorder Type I
A clinical trial of Schizophrenia and Bipolar I Disorder, sponsored by diaMentis.
- Active
- Registry status
- 300
- Enrollment target
- 19
- Study locations
NCT03788811 is a study of Schizophrenia and Bipolar I Disorder that is active but no longer recruiting, run by diaMentis. The registered enrollment target is 300 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (38% higher). The trial reports 19 study locations across 9 states.
The verdict
NCT03788811, a study of Schizophrenia and Bipolar I Disorder, is active but no longer recruiting, sponsored by diaMentis.
- ACTIVE NOT RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 19
- Study locations
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2018-07-05 |
| Est. Completion | 2026-12-31 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (38% higher). The listed sponsor is diaMentis, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT03788811 reports 19 study locations spanning 9 distinct geographic areas - top geographies include California, New York, Victoria.
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.
What interventions are being tested in trial NCT03788811?
The interventions under investigation include: ERG assessment (RSPA) (DEVICE).
Who is sponsoring clinical trial NCT03788811?
This trial is sponsored by diaMentis, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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