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.
Phase:
Phase 2
Details
Lead Sponsor:
Rachel Yehuda
Collaborators:
James J. Peters Veterans Affairs Medical Center The Chaim Sheba Medical Center