Post-Traumatic Stress Disorder > Hydrocortisone

Hydrocortisone for Preventing PTSD

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen By Rachel Yehuda, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Rachel Yehuda

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests whether a single dose of hydrocortisone (HCORT) can prevent PTSD in highly distressed trauma survivors. HCORT works by boosting the body's natural stress recovery system. If successful, this could provide a simple, portable treatment for those at high risk of PTSD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking oral steroids or have used benzodiazepines within 24 hours of trauma exposure.

What evidence supports the effectiveness of hydrocortisone in preventing PTSD?

Research shows that hydrocortisone, when given shortly after a traumatic event, can reduce the risk of developing PTSD. It also helps improve treatment outcomes and reduce dropout rates in therapy for PTSD by lessening the distress from traumatic memories.

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Is hydrocortisone safe for humans?

Hydrocortisone has been studied in various trials for its effects on post-traumatic stress disorder (PTSD) and has shown to be generally safe in humans. These studies involved different doses and methods of administration, and no significant safety concerns were reported.

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How does hydrocortisone differ from other drugs for preventing PTSD?

Hydrocortisone is unique in its use for preventing PTSD because it targets the body's stress response system (the hypothalamic-pituitary-adrenal axis) immediately after trauma, potentially reducing PTSD symptoms by stabilizing stress hormone levels. This approach is different from traditional psychological therapies and is still being explored as a novel pharmacological intervention.

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Eligibility Criteria

This trial is for adults who've recently experienced trauma, feel highly distressed or disconnected, and have a heart rate of 80 bpm or more. They must weigh between 99-242 lbs and not be severely injured, intoxicated, pregnant, on steroids or benzodiazepines, nor have certain chronic diseases or mental health conditions.

Inclusion Criteria

My weight is between 99 and 242 lbs.

I experienced a traumatic event within the last 6 hours.

I am 18 years old or older.

Exclusion Criteria

I have not been prescribed narcotics for acute pain in the emergency department.

I am currently taking oral steroids.

I am able to understand and agree to the study's procedures.

I have a severe injury or condition that needed surgery under general anesthesia.

My weight is between 99 lbs and 242 lbs.

I do not have conditions like unstable diabetes, heart failure, or active infections.

I have not taken benzodiazepines since experiencing trauma.

I lost consciousness for more than 30 minutes due to a recent severe head injury.

Participant Groups

The study tests if a single dose of hydrocortisone (HCORT), given within six hours after trauma can prevent PTSD compared to a placebo. It's randomized with assessments at multiple intervals post-treatment to measure the decline in PTSD symptoms and related mental health issues.

Group I: HCORT Active Control 1 Intervention

180 mg capsule PO

Group II: Placebo Placebo Group 1 Intervention

matching capsule PO

Hydrocortisone is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Hydrocortisone for:

• Adrenal insufficiency
• Allergic reactions
• Asthma
• Severe acute pancreatitis

🇺🇸 Approved in United States as Hydrocortisone for:

• Adrenal insufficiency
• Allergic reactions
• Asthma
• Severe acute pancreatitis

🇨🇦 Approved in Canada as Hydrocortisone for:

• Adrenal insufficiency
• Allergic reactions
• Asthma
• Severe acute pancreatitis

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Mount Sinai Morningside Emergency Department New York, NY

Icahn School of Medicine at Mount Sinai New York, NY

Who is running the clinical trial?

Rachel Yehuda Lead Sponsor

The Chaim Sheba Medical Center Collaborator

James J. Peters Veterans Affairs Medical Center Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Hydrocortisone suppression of the fear-potentiated startle response and posttraumatic stress disorder. [2021] This study examined the effects of oral administration of 20mg hydrocortisone on baseline and fear-potentiated startle in 63 male veterans with or without PTSD. The procedure was based on a two-session, within-subject design in which acoustic startle eyeblink responses were recorded during intervals of threat or no threat of electric shock. Results showed that the magnitude of the difference between startle responses recorded during anticipation of imminent shock compared to "safe" periods was reduced after hydrocortisone administration relative to placebo. This effect did not vary as a function of PTSD group nor were there were any significant group differences in other indices startle amplitude. Findings suggest that the acute elevations in systemic cortisol produced by hydrocortisone administration may have fear-inhibiting effects. This finding may have implications for understanding the role of hypothalamic-pituitary-adrenal (HPA)-axis function in vulnerability and resilience to traumatic stress.

2. England pubmed.ncbi.nlm.nih.gov

Cortisol augmentation of a psychological treatment for warfighters with posttraumatic stress disorder: Randomized trial showing improved treatment retention and outcome. [2022] Prolonged exposure (PE) therapy for post-traumatic stress disorder (PTSD) in military veterans has established efficacy, but is ineffective for a substantial number of patients. PE is also associated with high dropout rates. We hypothesized that hydrocortisone augmentation would enhance symptom improvement and reduce drop-out rates by diminishing the distressing effects of traumatic memories retrieved during imaginal exposure. We also hypothesized that in responders, hydrocortisone augmentation would be more effective in reversing glucocorticoid indices associated with PTSD than placebo augmentation.

3. United States pubmed.ncbi.nlm.nih.gov

Hydrocortisone in the emergency department: a prospective, double-blind, randomized, controlled posttraumatic stress disorder study. Hydrocortisone during golden hours. [2022] A blunted response of the hypothalamic-pituitary-adrenal axis immediately after exposure to traumatic events has been proposed as a risk factor for posttraumatic stress disorder (PTSD). Accordingly, administration of hydrocortisone in the aftermath of a traumatic event is indicated. This study consisted of a randomized, placebo-controlled, double-blind trial investigating whether a single intravenous dose of hydrocortisone administered within 6 hours after exposure to trauma would reduce the incidence of PTSD at the 13-month follow-up.

4. United States pubmed.ncbi.nlm.nih.gov

Placebo Effects Across Self-Report, Clinician Rating, and Objective Performance Tasks Among Women With Post-Traumatic Stress Disorder: Investigation of Placebo Response in a Pharmacological Treatment Study of Post-Traumatic Stress Disorder. [2022] For a drug to acquire Food and Drug Administration approval, it must significantly outperform placebo treatment. In recent years, the placebo effect seems to be increasing in neuropsychiatric conditions. Here, we examine placebo effects across self-reported, clinically rated, and performance-based data from a trial using a corticotropin-releasing hormone receptor type 1 (CRHR1) antagonist for treatment of post-traumatic stress disorder (PTSD).

5. United States pubmed.ncbi.nlm.nih.gov

The efficacy of initial hydrocortisone administration at preventing posttraumatic distress in adult trauma patients: a randomized trial. [2021] OBJECTIVE/INTRODUCTION: Secondary pharmacological interventions have shown promise at reducing the development of posttraumatic stress disorder symptoms (PTSS) in preclinical studies. The present study examined the preliminary efficacy of a 10-day low-dose (20 mg bid) course of hydrocortisone at preventing PTSS in traumatic injury victims.

6. England pubmed.ncbi.nlm.nih.gov

Hydrocortisone administration for reducing post-traumatic stress symptoms: A systematic review and meta-analysis. [2022] Post-traumatic stress disorder (PTSD) is a debilitating disorder that is often accompanied by alterations in the hypothalamic-pituitary (HPA) axis. While there is abundant evidence for the efficacy of psychological therapies in reducing post-traumatic stress symptoms, barely anything is known about pharmacological interventions. Given the role of the HPA axis in the pathophysiology of PTSD, the aim of this study was to provide the first meta-analysis of Hydrocortisone as a potential treatment for this condition.