Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · May 16, 2018

Keywords

ClinConnect Summary

This clinical trial, titled "Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests," is focused on understanding how to better predict which individuals with Posttraumatic Stress Disorder (PTSD) will respond to the medication prazosin. PTSD can greatly affect those who have experienced traumatic events, and while there are effective treatment options, it's often unclear who will benefit from a specific treatment. In this study, researchers will use simple tests to measure how a person's blood pressure changes when standing and how their eyes respond to light. This information may help determine if prazosin is the right treatment for them.

To participate in this trial, individuals must be U.S. veterans currently diagnosed with PTSD. They also need to meet certain health criteria, including not having severe psychiatric disorders or unstable medical conditions. Participants will undergo the mentioned tests and may continue any ongoing therapy, provided it doesn't interfere with the study. It's important to note that women who can become pregnant must agree to use effective birth control during the study. This research aims to improve treatment for PTSD by identifying which patients are likely to benefit from specific therapies, ultimately leading to better outcomes for those affected by this condition.

Gender

ALL

Eligibility criteria

• 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
• • 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.