NCT06363968

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: VA Puget Sound Health Care System · Federal
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, individuals will undergo an assessment that includes taking a history of their previous exposure to traumatic events, an assessment of current mental health symptoms including those associated with PTSD, and an assessment of physiologic measures, including ERG as well as vital sign measurements, blood draw, and saliva sampling. Participants will be given a single dose of sertraline (50mg), and a repeat ERG will be administered. An optional open label phase of the study will follow, in which participants who undergo treatment with an antidepressant will be invited back for a follow-up assessment with repeat ERG.

Conditions

• PTSD
• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	RETeval	as previous

Timeline

• Start date: 2024-02-12
• Primary completion: 2025-09-01
• Completion: 2030-09-01
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study