Using retinal biomarkers to predict mental health treatment outcomes in PTSD
Electroretinogram (ERG) as a Potential Biomarker of Serotonin Selective Reuptake Inhibitor (SSRI)-Responsive Posttraumatic Stress Disorder (PTSD): A Pilot Study
This study is testing if changes in eye signals can help predict how well veterans with PTSD will respond to a single dose of the medication sertraline.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | VA Puget Sound Health Care System Federal |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06363968 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the relationship between the electroretinogram (ERG) waveform and the effects of the selective serotonin reuptake inhibitor (SSRI) sertraline in veterans diagnosed with PTSD. Participants will undergo ERG recordings before and after receiving a single dose of sertraline, allowing researchers to assess changes in retinal signals associated with mental health. The study aims to determine if baseline ERG signals can predict the response to SSRI treatment, potentially providing a new biomarker for PTSD management.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans of the U.S. Armed Forces who have a current diagnosis of PTSD.
Not a fit: Patients with primary psychotic disorders, significant visual impairments, or those who have previously experienced adverse reactions to SSRIs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for PTSD by identifying patients who are likely to respond to SSRIs based on retinal biomarkers.
How similar studies have performed: While the use of retinal biomarkers in mental health treatment is a novel approach, previous studies have suggested potential correlations between retinal signals and brain activity related to mental health disorders.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seattle, Washington
- VA Puget Sound Health Care System — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Hendrickson, MD, PhD — VA Puget Sound Health Care System
- Study coordinator: Katharine J Liang, MD, PhD
- Email: katharine.liang@va.gov
- Phone: (206) 277-6538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.