ERG Biomarkers for PTSD Treatment
(BRIGHT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how sertraline, a medication for PTSD, affects signals in the eye that might connect to the brain. Researchers aim to determine if changes in these signals, measured by an electroretinogram (ERG), can reveal more about PTSD mechanisms and treatment responses. The trial is open to veterans with PTSD and involves checking ERG readings before and after one dose of sertraline. Participants should not have significant eye problems or certain other medical conditions. As an unphased trial, this study offers veterans a unique opportunity to contribute to groundbreaking PTSD treatment research.
Will I have to stop taking my current medications?
You will need to stop taking sertraline or other drugs that affect serotonin for at least 6 half-lives before the study and avoid them during the study.
What prior data suggests that this ERG biomarker is safe for use in PTSD studies?
Research has shown that sertraline is a safe and well-tolerated treatment for PTSD. Studies have found that people taking sertraline usually do not experience severe side effects. The FDA approved it for treating PTSD, confirming its safety. This approval makes it a reliable option for those considering participation in studies involving this medication.12345
Why are researchers excited about this trial?
Researchers are excited about using ERG (electroretinography) biomarkers for PTSD treatment because this approach offers a new way to evaluate the effectiveness of treatments like sertraline. Unlike traditional methods that rely on subjective reports of symptom improvement, ERG provides an objective, measurable change in brain activity. This could lead to quicker and more accurate assessments of how well a treatment is working. By incorporating ERG, doctors might be able to fine-tune treatment plans more effectively, potentially leading to faster relief for patients.
What evidence suggests that this trial's treatments could be effective for PTSD?
Research has shown that sertraline can help treat PTSD. In one study, 53% of patients reported feeling much or very much better after taking sertraline. Another study found that those who continued taking sertraline had a significantly lower chance of symptom recurrence compared to those who took a placebo. Sertraline is one of only two medications approved by the FDA for treating PTSD, highlighting its effectiveness. Overall, sertraline has helped many people with PTSD experience fewer symptoms and reduced risk of recurrence.
In this trial, participants will undergo ERG recording before and after a single dose of sertraline 50 mg to evaluate its effects.12678Who Is on the Research Team?
Rebecca Hendrickson, MD, PhD
Principal Investigator
VA Puget Sound Health Care System
Are You a Good Fit for This Trial?
This trial is for veterans with PTSD. Participants will have their eye's electrical activity (ERG) measured before and after taking sertraline, an approved medication for PTSD. They must be willing to share their PTSD symptoms and treatment history.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo ERG recordings, provide clinical information, and receive a single dose of sertraline
Follow-up
Participants are monitored for changes in ERG waveform and PTSD symptoms after sertraline administration
Open-label Extension (optional)
Participants who initiate antidepressant treatment through routine clinical care are invited back for a follow-up ERG recording
What Are the Treatments Tested in This Trial?
Interventions
- RETeval
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Puget Sound Health Care System
Lead Sponsor