Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 12/22/2018 |
| Start Date: | June 4, 2018 |
| End Date: | June 5, 2023 |
| Contact: | Rebecca C Hendrickson, MD PhD |
| Email: | Rebecca.Hendrickson@va.gov |
| Phone: | (206) 277-5054 |
Noradrenergic Biomarkers in PTSD: Precision Medicine & Mechanisms
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 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.
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 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.
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.
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.
Inclusion Criteria:
- Veteran of the U.S. Armed Forces
- Current diagnosis of PTSD (as documented in clinical chart and/or per participant
report; a rule out diagnosis from a VA provider accompanied by a referral to the VA
PTSD Outpatient Clinic (POC) will also be considered sufficient for inclusion)
- Woman of childbearing potential must agree to abstain from sexual relations that could
result in pregnancy or use an effective method of birth control acceptable to both
participant and study clinician during the study. Men are not required to use
contraception during the study.
Exclusion Criteria:
- Psychiatric:
- Any known diagnosis of a primary psychotic or major neurocognitive disorder,
including schizophrenia, brief psychotic disorder, or Alzheimer's or other
dementia, as well as bipolar type I
- Current substance use disorder (except caffeine-related disorders,
tobacco-related disorders, or cannabis intoxication) other than in remission for
at least 3 months. The use of cannabis other than that meeting criteria for
cannabis use disorder is not exclusionary. Use of cannabis will be documented.
- Severe psychiatric instability or severe situational life crises, including
evidence of being actively suicidal or homicidal, or any behavior which poses an
immediate danger to participant or others.
- Note: Nonsuicidal depression comorbid with PTSD will not be exclusionary.
Participants may continue in any concurrent psychotherapy or pharmacotherapy
in which they are participating, other than pharmacotherapeutic agents
specifically listed above. Participants with active suicidal ideation or
with depression severe enough to require psychiatric hospitalization will be
excluded.
- Medical:
- Significant bilateral visual loss (would preclude performing the PLR
measurements)
- 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, recent
myocardial infarction (within 6 months), congestive heart failure, preexisting
hypotension (systolic <110) or orthostatic hypotension (systolic drop > 20mmHg
after two minutes standing or any drop accompanied by dizziness); autoimmune
disorders; insulin-dependent diabetes
- Chronic renal or hepatic failure, acute pancreatitis, Meniere's disease, benign
positional 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 to
avoid these medications for the duration of the study
- Use of avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and
vardenafil (Levitra) will be not be permitted during the study dose titration
period because of increased risk of hypotension in combination with alpha-1
blockers, but will be allowed at 1/2 the usual starting dose following dose
titration
- Current use of nitrates, or of alternative medications or supplements with
significant vasodilatory properties (e.g., nitrate containing supplements)
Participants may also be excluded at the discretion of PI or study clinicians if
they appear to be unsuitable for this research study for a reason not detailed
here.
We found this trial at
1
site
Seattle, Washington 98108
Principal Investigator: Rebecca C. Hendrickson, MD PhD
Phone: 206-277-5054
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