Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363968
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-18
Brief Title:
Biomarkers in the Retina for Prognosticating Mental Health Treatments
Sponsor:
VA Puget Sound Health Care System
Organization:
VA Puget Sound Health Care System
Study Overview
Official Title:
Electroretinogram ERG as a Potential Biomarker of Serotonin Selective Reuptake Inhibitor SSRI-Responsive Posttraumatic Stress Disorder PTSD A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRIGHT
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
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
Detailed Description:
In this study individuals will undergo an assessment that includes taking a history of their previous exposure to traumatic events an assessment of current mental health symptoms including those associated with PTSD and an assessment of physiologic measures including ERG as well as vital sign measurements blood draw and saliva sampling Participants will be given a single dose of sertraline 50mg and a repeat ERG will be administered An optional open label phase of the study will follow in which participants who undergo treatment with an antidepressant will be invited back for a follow-up assessment with repeat ERG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None