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Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests

Phase 3
Recruiting
Conditions
Posttraumatic Stress Disorder
Registration Number
NCT03539614
Lead Sponsor
VA Office of Research and Development
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
70
Inclusion Criteria

Inclusion Criteria:<br><br> - Veteran of the U.S. Armed Forces<br><br> - Current diagnosis of PTSD (as documented in clinical chart and/or per participant<br> report; a rule out diagnosis from a VA provider accompanied by a referral to the VA<br> PTSD Outpatient Clinic (POC) will also be considered sufficient for inclusion)<br><br> - Woman of childbearing potential must agree to abstain from sexual relations that<br> could result in pregnancy or use an effective method of birth control acceptable to<br> both participant and study clinician during the study. Men are not required to use<br> contraception during the study.<br><br>Exclusion Criteria:<br><br> - Psychiatric:<br><br> - Any known diagnosis of a primary psychotic or major neurocognitive disorder,<br> including schizophrenia, brief psychotic disorder, or Alzheimer's or other<br> dementia, as well as bipolar type I<br><br> - Severe psychiatric instability or severe situational life crises, including<br> evidence of being actively suicidal or homicidal, or any behavior which poses<br> an immediate danger to participant or others.<br><br> - Note: Nonsuicidal depression comorbid with PTSD will not be exclusionary.<br> Participants may continue in any concurrent psychotherapy or<br> pharmacotherapy in which they are participating, other than<br> pharmacotherapeutic agents specifically listed above. Participants with<br> active suicidal ideation or with depression severe enough to require<br> psychiatric hospitalization will be excluded.<br><br> - Medical:<br><br> - Significant bilateral visual loss (would preclude performing the PLR<br> measurements)<br><br> - Current pregnancy or lactation<br><br> - Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist<br><br> - Acute or unstable chronic medical illness, including unstable angina, recent<br> myocardial infarction (within 6 months), congestive heart failure, preexisting<br> hypotension (systolic <110) or orthostatic hypotension (systolic drop > 20mmHg<br> after two minutes standing or any drop accompanied by dizziness); autoimmune<br> disorders; insulin-dependent diabetes<br><br> - Chronic renal or hepatic failure, acute pancreatitis, Meniere's disease, benign<br> positional vertigo, or narcolepsy<br><br> - Medication / treatment:<br><br> - Any use within the 7 days prior to baseline of prazosin, doxazosin, clonidine,<br> guanfacine, trazodone, or nonbenzodiazepine hypnotics, and/or unwillingness to<br> avoid these medications for the duration of the study<br><br> - Use of avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and<br> vardenafil (Levitra) will be not be permitted during the study dose titration<br> period because of increased risk of hypotension in combination with alpha-1<br> blockers, but will be allowed at 1/2 the usual starting dose following dose<br> titration<br><br> - Current use of nitrates, or of alternative medications or supplements with<br> significant vasodilatory properties (e.g., nitrate containing supplements)<br> Participants may also be excluded at the discretion of PI or study clinicians<br> if they appear to be unsuitable for this research study for a reason not<br> detailed here.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in total PTSD Checklist for DSM 5 (PCL5) score
Secondary Outcome Measures
NameTimeMethod
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