Phase 2 trial protocol tests oral hydrocortisone for PTSD prevention after trauma

Status: COMPLETED | Phase: PHASE2 Condition(s): PTSD, Acute Stress Disorder, Trauma-related Stressor Intervention(s): Placebo (DRUG), Hydrocortisone (DRUG) There is currently no evidence-based intervention for individuals exposed to trauma that is designed to aid recovery and prevent the development of post-traumatic stress disorder (PTSD). This randomized control trial proposes to test a one-time prophylactic treatment for the prevention of symptoms of PTSD and related mental health disturbances and the promotion of resilience using a single dose of hydrocortisone (HCORT) or placebo, administered within six hours of trauma exposure. People at risk for PTSD have demonstrated low cortisol levels before and in the aftermath of traumatic exposures and lower cortisol levels have also been observed in combat veterans with PTSD. Administering HCORT at the time of trauma would help boost the body's natural stress recovery systems to facilitate resilience. Participants who present to the emergency department following trauma exposure and report high distress, panic, anxiety or dissociation will be invited to participate in this clinical trial. 220 trauma survivors will be randomized and recruited at two locations: Mount Sinai Hospital in New York City, US, and a civilian/military hospital in Tel Hashomer, Israel. Trauma survivors will be assessed at 2, 6, 12 and 28 weeks post-treatment. HCORT closely resembles cortisol produced in the adrenal glands and released during stress. It is hypothesized that HCORT treatment will result in an accelerated decline in the presence and severity of PTSD and related mental health symptoms compared to the placebo group. Blood samples will be collected for analysis of potential biomarkers to obtain more information about the mechanisms of action of this intervention. The information obtained will be relevant in determining whether early intervention with a single dose of HCORT, compared to placebo, administered within several hours following trauma exposure, will reduce the risk of developing PTSD in trauma survivors. Detailed: Preliminary findings using HCORT in PTSD prevention have been encouraging. However, it is imperative to provide a more definitive study of HCORT effects across a wide range of demographic and traumatic exposures. In addition, prior studies used a single IV dose of HCORT administered in the Emergency Department (ED) and it is critical to determine whether effects would be comparable using oral HCORT. The advantage of an oral prophylactic is that a pill is a portable prophylactic that could be carried by first responders, military personnel and other people whose occupations expose them to risk of trauma exposure. The results of this RCT will add to the existing literature in several important ways. The study will be larger in scope, and will target a more extensive biological profile to el Primary Outcome(s): Clinician Administered PTSD Scale (CAPS) Enrollment: 201 (ACTUAL) Lead Sponsor: Rachel Yehuda Start: 2022-01-12 | Primary Completion: 2025-07-06