RecruitingNot ApplicableNCT06363968

Biomarkers in the Retina for Prognosticating Mental Health Treatments

Electroretinogram (ERG) as a Potential Biomarker of Serotonin Selective Reuptake Inhibitor (SSRI)-Responsive Posttraumatic Stress Disorder (PTSD): A Pilot Study


Sponsor

VA Puget Sound Health Care System

Enrollment

50 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether certain changes in the retina (the back of the eye) can predict how well veterans with PTSD will respond to treatment with sertraline (a common antidepressant). Researchers believe the eye may reflect changes happening in the brain during mental health treatment. **You may be eligible if...** - You are a U.S. military veteran - You have a current diagnosis of PTSD **You may NOT be eligible if...** - You have a diagnosis of a major psychotic disorder or significant cognitive decline (like dementia) - You have significant vision loss in both eyes - You have a history of acute angle-closure glaucoma, inherited retinal disease, or previous eye test (ERG) abnormalities - You have photosensitive epilepsy - You are pregnant or breastfeeding - You have liver failure - You have an eye injury or open wound around the eye - You are currently taking or recently used sertraline or other serotonin-acting medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICERETeval

as previous


Locations(1)

VA Puget Sound Health Care System

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06363968


Related Trials