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Biomarkers in the Retina for Prognosticating Mental Health Treatments
NCT06363968 · View on ClinicalTrials.gov ↗
Study Summary
Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot study Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are: 1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD? 2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment? Participants will be asked to: * Undergo ERG recordings before and after a single dose of sertraline. * Provide relevant clinical information related to PTSD symptoms and treatment history. Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording.
Conditions Studied
Interventions
- DEVICE RETeval
Study Locations (1)
Washington
- VA Puget Sound Health Care System — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-02-12 |
| Est. Completion | 2030-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06363968
The ClinicalTrials.gov registry entry for NCT06363968 describes a study currently listed as recruiting. It is categorized as NA, 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 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Puget Sound Health Care System, which has 7 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 PTSD appearing as the primary indexed condition, and to 1 intervention — of which RETeval 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: NCT06363968 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. 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 NCT06363968 about?
NCT06363968 is a clinical study titled "Biomarkers in the Retina for Prognosticating Mental Health Treatments". Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot study Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may b...
What is the current status of trial NCT06363968?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-02-12. Estimated completion is 2030-09-01.
What conditions does trial NCT06363968 study?
This clinical trial studies the following conditions: PTSD, Posttraumatic Stress 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 NCT06363968?
The interventions under investigation include: RETeval (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06363968?
This trial is sponsored by VA Puget Sound Health Care System, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06363968 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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