NCT06363968 Biomarkers in the Retina for Prognosticating Mental Health Treatments
| NCT ID | NCT06363968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Puget Sound Health Care System |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-02-12 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-02-12 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Veteran of the U.S. Armed Forces * Current diagnosis of PTSD Exclusion Criteria: * Known diagnosis of a primary psychotic or major neurocognitive disorder * Significant bilateral visual loss * History of acute angle closure glaucoma * Known inherited retinal disease * Previous ERG deficits * Known photosensitive epilepsy * Known current pregnancy or lactation * Allergy or previous adverse reaction to sertraline or SSRI * Allergy to Sensor Strip gel * Hepatic failure * Damage to orbit structure or open lesion in soft tissue surrounding the eye * Any use in the time period of at least 6 half-lives prior to baseline of sertraline or other drugs acting on serotonin and/or unwillingness to avoid these medications for the duration of the study.
Contact & Investigator
Rebecca Hendrickson, MD, PhD
PRINCIPAL INVESTIGATOR
VA Puget Sound Health Care System
Frequently Asked Questions
Who can join the NCT06363968 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06363968 currently recruiting?
Yes, NCT06363968 is actively recruiting participants. Contact the research team at katharine.liang@va.gov for enrollment information.
Where is the NCT06363968 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT06363968 clinical trial?
NCT06363968 is sponsored by VA Puget Sound Health Care System. The principal investigator is Rebecca Hendrickson, MD, PhD at VA Puget Sound Health Care System. The trial plans to enroll 50 participants.
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