PTSD Prevention Using Oral Hydrocortisone

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.

Conditions

• PTSD
• Acute Stress Disorder
• Trauma-related Stressor

Interventions

DRUG

Placebo

Inactive dose of capsules that appear identical to active dose

DRUG

Hydrocortisone

Hydrocortisone 180 mg in capsule form

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center

  collaborator FED

• The Chaim Sheba Medical Center

  collaborator OTHER

• Rachel Yehuda

  lead OTHER

Principal Investigators

• Rachel Yehuda, PhD · Icahn School of Medicine at Mount Sinai; James J. Peters Veterans Affairs Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-12

Primary Completion

2025-07-06

Completion

2025-07-06

FDA Drug

Yes

Countries

• United States
• Israel

Study Locations