Hydrocortisone for Prevention of Post-Traumatic Stress Disorder

• Status: Withdrawn
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein Healthcare Network
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

1. Older than age 18

2. Presenting to ER for treatment of injuries sustained in a violent physical assault

3. Assault met DSM-IV "A" criterion (in patient's view, the assault involved or threatened death or serious injury)

4. Patient will be discharged home from Emergency Room

Exclusion Criteria:

1. Intoxicated due to drugs, alcohol or medication at the time they are approached.

2. Under arrest or in police custody at the time they are approached.

3. No memory of the assault

4. Cognitive impairment or psychosis identified by the treating physician or on chart review.

5. Patients whose presenting injury is a result of domestic (i.e. injured by a primary caregiver or significant other) or sexual violence

6. Under age 18

7. Not medically stable enough to participate

8. Non-English speakers

9. Pregnant or nursing women

10. Already on steroid treatment

11. Immunosuppressed (taking immunosuppressant medication, cancer undergoing active chemotherapy, AIDS, HIV not on HAART therapy)

12. Have an active infection identified by the treating physician or on chart review

13. Allergy or adverse reaction to hydrocortisone or other corticosteroids

14. Diabetic

15. On warfarin therapy