NCT03539614

Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests

Noradrenergic Biomarkers in PTSD: Precision Medicine & Mechanisms

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. There are a variety of treatment options for PTSD, including psychotherapy (talk therapy) options, as well as medications, such as the drug prazosin. Each of the treatment options available is effective at significantly reducing the symptoms of PTSD in some, but not all, individuals with PTSD. However, investigators are not yet able to predict in advance who is likely to respond to which of the available treatments. Neither are the investigators able to explain what changes in the brain after exposure to a traumatic stressors, and why it results in persistent symptoms of PTSD for some people, but not for others. In this study, the investigators are testing two things: First, is testing whether two simple, easy tests of how an individual's blood pressure changes with standing and how an individual's eye reacts to a pulse of light may be able to predict whether that person is likely to respond to the medication prazosin for PTSD. Second, is testing whether those who have been exposed to a traumatic stress show differences in how their body regulates the response to the stress-signal noradrenaline.

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, such as blood pressure and pupillary responses to light. For individuals who have current symptoms of PTSD and for whom use of the medication prazosin is a reasonable and safe option, a second phase of the study will be offered. In this second phase, how the individual's PTSD symptoms change when taking prazosin will be assessed. In addition, to test whether any changes are related to the prazosin itself or are part of a placebo effect, the individual will be randomly assigned to periods where he or she is taking a pill that looks like prazosin but is actual placebo (a pill with no active ingredient), and periods where he or she is taking a pill that looks the same but this time is actual prazosin. Of note, there is also an additional observational portion of the protocol that is not a direct part of the interventional trial described here, but data from which will be used to help to interpret the data from the interventional trial; because reporting of study results depends on both portiosn, the study completion date estimates/reports will reflect when both the interventional and observational trial components are complete.

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Prazosin	This is an antagonist of the alpha1 receptor for noradrenaline. It is FDA approved for the treatment of hypertension, and has also been used for benign prostatic hypertrophy (BPH). Most recently, it has been found to be helpful for symptoms of PTSD in some but not all participants.
DRUG	Placebo	This is a capsule containing an inert substance, in order to provide blinding to participants and study staff of when participants are on active medication and when they are not during the later portions of the trial.

Timeline

• Start date: 2018-06-04
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2018-05-29
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study