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NCT06363968 · ClinicalTrials.gov registry record · NA
Biomarkers in the Retina for Prognosticating Mental Health Treatments
A NA study of Post Traumatic Stress Disorder and PTSD, sponsored by VA Puget Sound Health Care System.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06363968: Recruiting NA study of Post Traumatic Stress Disorder and PTSD, sponsored by VA Puget Sound Health Care System.
NCT06363968 is a NA study of Post Traumatic Stress Disorder and PTSD that is actively recruiting participants, run by VA Puget Sound Health Care System. The registered enrollment target is 50 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06363968, a NA study of Post Traumatic Stress Disorder and PTSD, 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.
Primary Outcome
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.
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 |
What NCT06363968 shows while recruiting
NCT06363968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which RETeval is the first listed.
NCT06363968 reports a single indexed study location in 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: Post Traumatic Stress Disorder, PTSD.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06363968's enrollment target sits among peer trials
50 176th of 262 higher than 83 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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