Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests

Last updated: August 1, 2025
Sponsor: VA Office of Research and Development
Overall Status: Active - Not Recruiting

Phase

3

Condition

Post-traumatic Stress Disorders

Treatment

Placebo

Prazosin

Clinical Study ID

NCT03539614
MHBB-003-17F
1IK2CX001774-01
  • Ages 21-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Veteran of the U.S. Armed Forces

  • Current diagnosis of PTSD (as documented in clinical chart and/or per participantreport; a rule out diagnosis from a VA provider accompanied by a referral to the VAPTSD Outpatient Clinic (POC) will also be considered sufficient for inclusion)

  • Woman of childbearing potential must agree to abstain from sexual relations thatcould result in pregnancy or use an effective method of birth control acceptable toboth participant and study clinician during the study. Men are not required to usecontraception during the study.

Exclusion

Exclusion Criteria:

  • Psychiatric:

  • Any known diagnosis of a primary psychotic or major neurocognitive disorder,including schizophrenia, brief psychotic disorder, or Alzheimer's or otherdementia, as well as bipolar type I

  • Severe psychiatric instability or severe situational life crises, includingevidence of being actively suicidal or homicidal, or any behavior which posesan immediate danger to participant or others.

  • Note: Nonsuicidal depression comorbid with PTSD will not be exclusionary.Participants may continue in any concurrent psychotherapy orpharmacotherapy in which they are participating, other thanpharmacotherapeutic agents specifically listed above. Participants withactive suicidal ideation or with depression severe enough to requirepsychiatric hospitalization will be excluded.

  • Medical:

  • Significant bilateral visual loss (would preclude performing the PLRmeasurements)

  • Current pregnancy or lactation

  • Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist

  • Acute or unstable chronic medical illness, including unstable angina, recentmyocardial infarction (within 6 months), congestive heart failure, preexistinghypotension (systolic <110) or orthostatic hypotension (systolic drop > 20mmHgafter two minutes standing or any drop accompanied by dizziness); autoimmunedisorders; insulin-dependent diabetes

  • Chronic renal or hepatic failure, acute pancreatitis, Meniere's disease, benignpositional vertigo, or narcolepsy

  • Medication / treatment:

  • Any use within the 7 days prior to baseline of prazosin, doxazosin, clonidine,guanfacine, trazodone, or nonbenzodiazepine hypnotics, and/or unwillingness toavoid these medications for the duration of the study

  • Use of avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), andvardenafil (Levitra) will be not be permitted during the study dose titrationperiod because of increased risk of hypotension in combination with alpha-1blockers, but will be allowed at 1/2 the usual starting dose following dosetitration

  • Current use of nitrates, or of alternative medications or supplements withsignificant vasodilatory properties (e.g., nitrate containing supplements)Participants may also be excluded at the discretion of PI or study cliniciansif they appear to be unsuitable for this research study for a reason notdetailed here.

Study Design

Total Participants: 87
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 04, 2018
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington 98108-1532
    United States

    Site Not Available

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