Biomarkers in the Retina for Prognosticating Mental Health Treatments
NCT ID: NCT06363968
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-02-12
2030-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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ERG, all participants
All participants undergo ERG recording before and after a single dose of sertraline 50 mg.
RETeval
as previous
Interventions
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RETeval
as previous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current diagnosis of PTSD
Exclusion Criteria
* 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.
21 Years
75 Years
ALL
No
Sponsors
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VA Puget Sound Health Care System
FED
Responsible Party
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Principal Investigators
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Rebecca Hendrickson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System
Locations
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VA Puget Sound Health Care System
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1743326
Identifier Type: -
Identifier Source: org_study_id
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