RECRUITING

Biomarkers in the Retina for Prognosticating Mental Health Treatments

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Electroretinogram (ERG) as a Potential Biomarker of Serotonin Selective Reuptake Inhibitor (SSRI)-Responsive Posttraumatic Stress Disorder (PTSD): A Pilot Study

Quick Facts

Study Start:2024-02-12
Study Completion:2030-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06363968

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran of the U.S. Armed Forces
  2. * Current diagnosis of PTSD
  1. * Known diagnosis of a primary psychotic or major neurocognitive disorder
  2. * Significant bilateral visual loss
  3. * History of acute angle closure glaucoma
  4. * Known inherited retinal disease
  5. * Previous ERG deficits
  6. * Known photosensitive epilepsy
  7. * Known current pregnancy or lactation
  8. * Allergy or previous adverse reaction to sertraline or SSRI
  9. * Allergy to Sensor Strip gel
  10. * Hepatic failure
  11. * Damage to orbit structure or open lesion in soft tissue surrounding the eye
  12. * 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.

Contacts and Locations

Study Contact

Katharine J Liang, MD, PhD
CONTACT
(206) 277-6538
katharine.liang@va.gov
Rebecca C Hendrickson
CONTACT
206-277-5054
rebecca.hendrickson@va.gov

Principal Investigator

Rebecca Hendrickson, MD, PhD
PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System

Study Locations (Sites)

VA Puget Sound Health Care System
Seattle, Washington, 98108
United States

Collaborators and Investigators

Sponsor: VA Puget Sound Health Care System

  • Rebecca Hendrickson, MD, PhD, PRINCIPAL_INVESTIGATOR, VA Puget Sound Health Care System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12
Study Completion Date2030-09-01

Study Record Updates

Study Start Date2024-02-12
Study Completion Date2030-09-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • PTSD
  • Posttraumatic Stress Disorder