PTSD Prevention Using Oral Hydrocortisone

ID#: NCT04924166

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: September 23, 2021

End Date: April 01, 2023

Contact Information:
Heather Bader, BS
Hunter Carney, BS
Summary: 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.

Inclusion Criteria:

1. Age ≥ 18 years

2. Weight: 99 lb

- 242 lbs

3. Experienced a traumatic event less than 6 hours ago Secondary

Inclusion Criteria: ED staff note marked anxiety emotional distress and or dissociation in relation to index trauma as assessed by meeting a minimum of 2 out of 4 of the peritraumatic characteristics that have been associated with the development of PTSD below:

1. Anxiety Visual Analog Scale minimum score of 4 on a scale of 0 to 10

2. Peritraumatic dissociation (PDEQ) with a cut-point of 15 (lowest possible score is 10)

3. Peritraumatic distress (Peritraumatic Distress Inventory) (PDI) with a cut-point of 15 (lowest possible score is 0)

4. Heart rate at 80 bpm or more

Exclusion Criteria:

1. Severe physical injury as assessed with the Abbreviated Injury Scale (AIS > 2); Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by clinical judgment.

2. Inability to provide informed consent or cooperate with the screening or collection of initial measures.

3. Intoxication to a degree that would interfere with the ability to provide informed consent or high level or intoxication reported at the time of trauma.

4. Moderate to severe head injury associated with current trauma exposure as defined by a loss of consciousness >30 minutes following injury.

5. Medical conditions e.g., Cushing's syndrome, current acute infectious or viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, heart failure.

6. Currently taking oral steroids

7. Use of benzodiazepine within 24 hours of trauma exposure will not be eligible to participate in the study

8. Individuals prescribed a narcotic medication to alleviate acute pain in the ED will not be eligible to participate in the treatment study.

9. Weight below 45kg or above 110 kg (99 lbs

- 242 lbs)

10. Pregnancy (a urine pregnancy test will be performed in the ED)

11. Individuals experiencing on-going trauma (i.e., domestic violence).

12. Reported diagnoses of schizophrenia, bipolar I disorder, or other psychotic illness.

13. Current or past history of dementia, amnesia or other cognitive disorder predating trauma exposure

14. Residence outside local area, which would hinder attendance at follow up visits due to long travel time.