Predicting PTSD treatment responses using eye and blood pressure tests
Noradrenergic Biomarkers in PTSD: Precision Medicine & Mechanisms
PHASE3 · VA Office of Research and Development · NCT03539614
This study is testing whether eye and blood pressure tests can help predict how well people with PTSD will respond to the medication prazosin compared to a placebo.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT03539614 on ClinicalTrials.gov |
What this trial studies
This study aims to identify predictors of treatment response in individuals with posttraumatic stress disorder (PTSD) by assessing physiological measures such as blood pressure changes and pupillary responses to light. Participants will undergo a comprehensive evaluation of their trauma history and current PTSD symptoms. Those eligible will be randomly assigned to receive either the medication prazosin or a placebo to evaluate changes in their PTSD symptoms. The study also includes an observational component to enhance data interpretation.
Who should consider this trial
Good fit: Ideal candidates for this study are U.S. Armed Forces veterans currently diagnosed with PTSD.
Not a fit: Patients with primary psychotic disorders or severe psychiatric instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for individuals with PTSD.
How similar studies have performed: While there have been studies exploring predictors of treatment response in PTSD, this specific approach using physiological measures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seattle, Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Rebecca C. Hendrickson, MD PhD — VA Puget Sound Health Care System Seattle Division, Seattle, WA
- Study coordinator: Rebecca C Hendrickson, MD PhD
- Email: Rebecca.Hendrickson@va.gov
- Phone: (206) 277-5054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Posttraumatic Stress Disorder, Prazosin, Nightmares, N-of-1