Biomarkers in the Retina for Prognosticating Mental Health Treatments

Part of paid clinical trials in Seattle, Washington.

Sponsor
VA Puget Sound Health Care System
Study ID
NCT06363968
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RETeval — DEVICE
    as previous

Study Details

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.

Key Dates

Start date
Feb 12, 2024
Status verified
Apr 2024
Primary completion
Sep 1, 2025
Completion
Sep 1, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: ERG, all participants
    All participants undergo ERG recording before and after a single dose of sertraline 50 mg.

Primary Outcome Measure

ERG b-wave amplitude response to SSRI [ Time Frame: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Puget Sound Health Care SystemSeattleWashington98108
Rebecca C Hendrickson, MD, PhD
[email protected]
206-277-5054
Katharine J Liang, MD, PHD (SUB_INVESTIGATOR)
Rebecca C Hendrickson, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
VA Puget Sound Health Care System· Seattle, WA

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