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NCT06363968 · ClinicalTrials.gov registry record · NA
Biomarkers in the Retina for Prognosticating Mental Health Treatments
A NA study of PTSD and Posttraumatic Stress Disorder, sponsored by VA Puget Sound Health Care System.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06363968 is a NA study of PTSD and Posttraumatic Stress Disorder that is actively recruiting participants, run by VA Puget Sound Health Care System. The registered enrollment target is 50 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06363968, a NA study of PTSD and Posttraumatic Stress Disorder, is actively recruiting participants, sponsored by VA Puget Sound Health Care System.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE RETeval
Study Locations (1)
Washington
- VA Puget Sound Health Care System - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-02-12 |
| Est. Completion | 2030-09-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06363968
The ClinicalTrials.gov registry entry for NCT06363968 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (83% lower). The listed sponsor is VA Puget Sound Health Care System, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 1 intervention - of which RETeval is the first listed.
NCT06363968 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT06363968 about?
NCT06363968 is a clinical study titled "Biomarkers in the Retina for Prognosticating Mental Health Treatments". 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 b...
What is the current status of trial NCT06363968?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-02-12. Estimated completion is 2030-09-01.
What conditions does trial NCT06363968 study?
This clinical trial studies the following conditions: PTSD, Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT06363968?
The interventions under investigation include: RETeval (DEVICE).
Who is sponsoring clinical trial NCT06363968?
This trial is sponsored by VA Puget Sound Health Care System, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06363968 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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