Hydrocortisone for Prevention of Post-Traumatic Stress Disorder
Status:
Withdrawn
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
Post-Traumatic Stress Disorder (PTSD) is an acquired psychiatric condition that occurs after
exposure to a dangerous or life-threatening event. It is characterized by persistent fear-
and stress-related symptoms, such as nightmares, flashbacks, depression, anxiety and guilt.
These symptoms can interfere significantly with patients' lives and in some cases can be
debilitating. One of the most frequent causes of PTSD is being a victim of a violent,
interpersonal assault.
PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded
too strongly in a patient's long-term memory, remaining too accessible and "present" to the
patient long after the actual threat has passed. In recent years evidence has emerged that it
may be possible to prevent PTSD by moderating the process of memory consolidation that occurs
in the hours and days after a traumatic event.
Early research has suggested that enhancing the body's natural cortisol response to a
stressful event may be a safe and effective way of moderating the process of memory
consolidation and promoting adaptive, non-pathological memory encoding. In particular, the
administration of hydrocortisone, a safe and widely used drug that mimics the body's own
cortisol hormone, appears to reduce the risk of developing PTSD in patients who have
sustained a traumatic event. However, this research is still in relatively early stages, and
requires larger trials to confirm its efficacy. In addition, the research thus far has not
adequately targeted assault victims, whom Investigator feel are some of the patients most
likely to benefit from such an approach.
Investigators propose a prospective, placebo-controlled, double-blinded trial of
administering single-dose oral hydrocortisone or placebo to 100 assault victims seen in the
Einstein Medical Center Philadelphia Emergency Department to determine if this approach has
efficacy in preventing PTSD. This study is designed as a pilot study, with the hopes that the
data gathered in it can be used to design a larger and more robust trial in the future.