Posttraumatic Stress Disorder, PTSD
Conditions
Keywords
PTSD, posttraumatic stress disorder, SSRI, antidepressant, serotonin, electroretinogram, ERG
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.
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.
Interventions
DEVICERETeval
as previous
Sponsors
VA Puget Sound Health Care System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Veteran of the U.S. Armed Forces * Current diagnosis of PTSD
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ERG b-wave amplitude response to SSRI | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score | 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. | CAPS-5 administered at baseline |
| Total PTSD Checklist for DSM-5 (PCL-5) | 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. | Self report PTSD Checklist (PCL-5) administered at baseline |
Countries
United States
Contacts
Primary ContactKatharine J Liang, MD, PhD
Backup ContactRebecca C Hendrickson
Outcome results
None listed