Actively Recruiting
Electroretinogram (ERG) as a Potential Biomarker of SSRI-Responsive PTSD: A Pilot Study in Veterans
Led by VA Puget Sound Health Care System · Updated on 2024-04-12
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the electroretinogram (ERG) as a potential biomarker in veterans diagnosed with posttraumatic stress disorder (PTSD). The study focuses on how a single dose of the selective serotonin reuptake inhibitor (SSRI) sertraline affects ERG waveforms. Researchers want to understand the relationship between baseline ERG signals and changes after SSRI treatment, providing insight into brain-retina connections related to PTSD. Participants will undergo ERG recordings before and after taking a single 50 mg dose of sertraline. The study includes assessments of PTSD symptoms, treatment history, and physiological measures such as vital signs, blood draws, and saliva samples. After these initial steps, participants who start antidepressant treatment in routine care may join an optional open-label phase to have a follow-up ERG recorded within a year. During the study, veterans will provide clinical information and undergo several evaluations, including PTSD symptom assessments and physiological tests. Outcome measures include changes in ERG b-wave amplitude before and after sertraline, as well as PTSD symptom scores from the CAPS-5 and PCL-5 scales. Safety and effects are monitored through these assessments over the study period, which may last up to one year for some participants.
CONDITIONS
Brief Title
Biomarkers in the Retina for Prognosticating Mental Health Treatments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran of the U.S. Armed Forces
- Current diagnosis of PTSD
- Age between 21 and 75 years
You will not qualify if you...
- 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
- 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
- Use of sertraline or other serotonin-acting drugs within 6 half-lives before baseline or unwillingness to avoid these during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants receive a single dose of sertraline (50 mg) and undergo electroretinogram (ERG) assessments before and after dosing, along with mental health and physiologic evaluations.
2 visits (in-person)
Duration - Up to 1 year
Participants who enter the optional open label phase and receive antidepressant treatment are invited back for follow-up assessments including repeat ERG and PTSD symptom evaluations.
1 or more visits depending on treatment phase
Trial Site Locations
Total: 1 location
1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Actively Recruiting
Research Team
K
Katharine J Liang, MD, PhD
R
Rebecca C Hendrickson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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