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Biomarkers in the Retina for Prognosticating Mental Health Treatments
NCT06363968 · VA Puget Sound Health Care System
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Electroretinogram (ERG) as a Potential Biomarker of Serotonin Selective Reuptake Inhibitor (SSRI)-Responsive Posttraumatic Stress Disorder (PTSD): A Pilot Study
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 50 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-12
Estimated completion: 2030-09-01
Last updated: 2024-04-12
Interventions
Device: RETeval
Primary outcomes
- • 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.)
Sponsor
VA Puget Sound Health Care System · fed
Contacts & investigators
ContactKatharine J Liang, MD, PhD · contact · katharine.liang@va.gov · (206) 277-6538
ContactRebecca C Hendrickson · contact · rebecca.hendrickson@va.gov · 206-277-5054
InvestigatorRebecca Hendrickson, MD, PhD · principal_investigator, VA Puget Sound Health Care System
All locations (1)
VA Puget Sound Health Care SystemRecruiting
Seattle, Washington, United States