Recruiting

Biomarkers

Sponsor:

VA Puget Sound Health Care System

Code:

NCT06363968

Conditions

PTSD

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

RETeval

Study Details

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.

Conditions

PTSD

Posttraumatic Stress Disorder

Study ID

NCT06363968

Start date

Feb 12, 2024

Status verified date

Apr, 2024

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: ERG, all participants

All participants undergo ERG recording before and after a single dose of sertraline 50 mg.

Interventions

RETeval

as previous

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 and Locations

Central contacts

Katharine J Liang, MD, PhD

(206) 277-6538katharine.liang@va.gov

Rebecca C Hendrickson

206-277-5054rebecca.hendrickson@va.gov

Locations

VA Puget Sound Health Care System

Recruiting

Seattle, Washington, United States, 98108

Contacts

Rebecca C Hendrickson, MD, PhD

206-277-5054rebecca.hendrickson@va.gov

Principal Investigator:

Rebecca C Hendrickson, MD, PhD

More Information

Sponsor

VA Puget Sound Health Care System

Last update posted

Apr 12, 2024

Last verified

Apr, 2024

Keywords

  • PTSD
  • posttraumatic stress disorder
  • SSRI
  • antidepressant
  • serotonin
  • electroretinogram
  • ERG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Puget Sound Health Care System on 2024-04-12.