Biomarkers in the Retina for Prognosticating Mental Health Treatments

This study is looking at how the retina (the light-sensitive tissue at the back of your eye) might help us understand and treat Posttraumatic Stress Disorder (PTSD). Researchers believe there's a link between the brain and the retina, and that a test called an electroretinogram (ERG), which measures electrical activity in the retina, could be a useful tool. This pilot study will examine the ERG in U.S. military veterans with PTSD before and after they take a single dose of sertraline, a medication approved for PTSD. The goal is to see if ERG changes can tell us more about how well treatments like sertraline might work for PTSD. The study aims to enroll 50 participants.

Study design
This is an interventional pilot study with a planned enrollment of 50 participants. It involves taking an initial ERG, then taking a single dose of sertraline, and having a repeat ERG the next day.
What's involved
You would have an assessment including a history of traumatic events, mental health symptoms, ERG, vital signs, blood draw, and saliva sampling. You would then take a single dose of sertraline (50mg) and have a repeat ERG the following day. Some participants may also have a follow-up ERG up to one year later.
Compensation
Not stated in the trial record.
Follow-up
For a subset of participants, ERGs will be performed at a follow-up visit up to 1 year following baseline.

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NCT06363968

Biomarkers in the Retina for Prognosticating Mental Health Treatments

Recruiting
NAAges 21–75InterventionalDevice feasibility
VA Puget Sound Health Care System
~50 participants
Updated 2024-04-12 on ClinicalTrials.gov
What's tested:RETeval

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ERG b-wave amplitude response to SSRI
Measured over ERGs will be performed at the baseline visit prior to a single dose of sertraline, and again after sertraline the following day. ERG will also be performed at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.
PTSD
Posttraumatic Stress Disorder
1 sites across 1 states
Washington1
  • Rebecca Hendrickson, MD, PhD · PRINCIPAL_INVESTIGATOR · VA Puget Sound Health Care System

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Eligibility criteria

Inclusion

Veteran of the U.S. Armed Forces
Current diagnosis of PTSD

Exclusion

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.
  • ERG b-wave amplitude response to SSRIERGs will be performed at the baseline visit prior to a single dose of sertraline, and again after sertraline the following day. ERG will also be performed at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.

    The change in b-wave amplitude following a single dose of sertraline compared to baseline b-wave amplitude will be calculated. The relationship between baseline b-wave amplitude and change in b-wave amplitude will be analyzed.