Biomarkers in the Retina for Prognosticating Mental Health Treatments

NCT06363968 | Recruiting FDA Device

• 1 other identifier: 1743326
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• ERG b-wave amplitude response to SSRI

  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.

  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.

Secondary Outcomes (2)

• Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score

  PTSD measures will be collected as a part of the baseline assessment. CAPS-5 will also be readministered at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.

• Total PTSD Checklist for DSM-5 (PCL-5)

  PTSD measures will be collected as a part of the baseline assessment. PCL-5 will also be repeated at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.

Study Arms (1)

ERG, all participants

EXPERIMENTAL

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

Device: RETeval

Interventions

RETeval DEVICE

as previous

Also known as: electroretinogram, ERG

ERG, all participants

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Puget Sound Health Care System: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Electroretinography

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Rebecca Hendrickson, MD, PhD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine J Liang, MD, PhD

CONTACT

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

Rebecca C Hendrickson

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 12, 2024
• Study Start: February 12, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

US (1)