PTSDBRIGHTNCT06363968
Biomarkers in the Retina for Prognosticating Mental Health Treatments
A study testing RETeval in people with PTSD and Posttraumatic Stress Disorder, run by VA Puget Sound Health Care System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- PTSD, Posttraumatic Stress Disorder
- What is being tested?
- RETeval
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran of the U.S. Armed Forces
- Current diagnosis of PTSD
Who cannot join
- 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
Show all 12Show fewer
- Known 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
- Any use in the time period of at least 6 half-lives prior to baseline of sertraline or other drugs acting on serotonin and/or unwillingness to avoid these medications for the duration of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Puget Sound Health Care System
Seattle, Washington, 98108
Rebecca C Hendrickson, MD, PhD, 206-277-5054, rebecca.hendrickson@va.gov
Katharine J Liang, MD, PHD
About this study
Official title: Electroretinogram (ERG) as a Potential Biomarker of Serotonin Selective Reuptake Inhibitor (SSRI)-Responsive Posttraumatic Stress Disorder (PTSD): A Pilot Study
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:
Read more
- How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD?
- 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.
Read the 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.
- Conditions
- PTSD, Posttraumatic Stress Disorder
- Being tested
- RETeval
- Keywords
- PTSD, posttraumatic stress disorder, SSRI, antidepressant, serotonin, electroretinogram, ERG
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RETevalDevice
Also called electroretinogram, ERG
as previous
| Study group | Role | What they receive |
|---|---|---|
| ERG, all participants | Experimental | All participants undergo ERG recording before and after a single dose of sertraline 50 mg. Receives: Device: RETeval |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERG b-wave amplitude response to SSRI
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.
Measured: ERGs will be performed at the baseline visit prior to a single dose of sertraline, and again after sertraline the following day. ERG will also be performed at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.
Secondary outcomes (2)
Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score
CAPS-5 administered at baseline
Measured: PTSD measures will be collected as a part of the baseline assessment. CAPS-5 will also be readministered at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.
Total PTSD Checklist for DSM-5 (PCL-5)
Self report PTSD Checklist (PCL-5) administered at baseline
Measured: PTSD measures will be collected as a part of the baseline assessment. PCL-5 will also be repeated at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start12 Feb 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rebecca Hendrickson, MD, PhD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363968
- Sponsor's protocol ID
- 1743326
- Acronym
- BRIGHT
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroretinogram (ERG) as a Potential Biomarker of Serotonin Selective Reuptake Inhibitor (SSRI)-Responsive Posttraumatic Stress Disorder (PTSD): A Pilot Study
- ClinicalTrials.gov ID
- NCT06363968
- Acronym / sponsor ID
- BRIGHT / 1743326
- Conditions
- PTSD, Posttraumatic Stress Disorder
- Keywords
- PTSD, posttraumatic stress disorder, SSRI, antidepressant, serotonin, electroretinogram, ERG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD?
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERG, all participants | Experimental | Device: RETevalAll participants undergo ERG recording before and after a single dose of sertraline 50 mg. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veteran of the U.S. Armed Forces
- Current diagnosis of PTSD
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RETevalAlso: electroretinogram, ERGas previous | Device | ERG, all participants |
Primary outcome
ERG b-wave amplitude response to SSRI
Time frame: ERGs will be performed at the baseline visit prior to a single dose of sertraline, and again after sertraline the following day. ERG will also be performed at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.
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.
2 secondary outcomes
Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score
Time frame: PTSD measures will be collected as a part of the baseline assessment. CAPS-5 will also be readministered at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.
Total PTSD Checklist for DSM-5 (PCL-5)
Time frame: PTSD measures will be collected as a part of the baseline assessment. PCL-5 will also be repeated at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Hendrickson, MD, PhD principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RETeval in people with PTSD and Posttraumatic Stress Disorder, run by VA Puget Sound Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharine J Liang, MD, PhD ((206) 277-6538, katharine.liang@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERG b-wave amplitude response to SSRI (time frame: ERGs will be performed at the baseline visit prior to a single dose of sertraline, and again after sertraline the following day. ERG will also be performed at the follow up visit for a subset of participants who qualify, up to 1 year following baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.