Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Posttraumatic Stress Disorder
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This study is a modified cross-over study, also called an aggregated N-of-1 study. Each participant who meets criteria for participation in and completes the treatment portion of the study will spend time on open-label prazosin, blinded prazosin, and placebo.Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: During the portion of the study where participants are receiving either placebo or blinded prazosin, the participants, care providers, and outcomes assessors will all be blinded as to whether the participant is at that time receiving prazosin or placebo.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 75 years
- Gender
- Both males and females
Description
Enrollment is currently paused due to COVID-19 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 m...
Enrollment is currently paused due to COVID-19 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.
Tracking Information
- NCT #
- NCT03539614
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Rebecca C. Hendrickson, MD PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
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