← Back to Search

Corticosteroid

Hydrocortisone for Preventing PTSD

Phase 2
Recruiting
Led By Rachel Yehuda, PhD
Research Sponsored by Rachel Yehuda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight: 99 lb - 242 lbs
Experienced a traumatic event less than 6 hours ago
Must not have
Individuals prescribed a narcotic medication to alleviate acute pain in the ED will not be eligible to participate in the treatment study.
Currently taking oral steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 months
Awards & highlights

Summary

This trial proposes to test whether a single dose of hydrocortisone, administered within six hours of exposure to trauma, can prevent the development of post-traumatic stress disorder (PTSD).

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not detailed but may include those typical of corticosteroids like mood swings, increased blood pressure, sleep problems, weight gain, and elevated blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is between 99 and 242 lbs.
Select...
I experienced a traumatic event within the last 6 hours.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not been prescribed narcotics for acute pain in the emergency department.
Select...
I am currently taking oral steroids.
Select...
I am able to understand and agree to the study's procedures.
Select...
I have a severe injury or condition that needed surgery under general anesthesia.
Select...
My weight is between 99 lbs and 242 lbs.
Select...
I do not have conditions like unstable diabetes, heart failure, or active infections.
Select...
I have not taken benzodiazepines since experiencing trauma.
Select...
I lost consciousness for more than 30 minutes due to a recent severe head injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician Administered PTSD Scale (CAPS)
Secondary outcome measures
Change in The Clinical Global Impression - Severity (CGI-S)
Change in the Clinical Global Impression - Improvement (CGI-I)
Montgomery-Asberg Depression Rating Scale (MADRS)
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: HCORTActive Control1 Intervention
180 mg capsule PO
Group II: PlaceboPlacebo Group1 Intervention
matching capsule PO

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Post-Traumatic Stress Disorder (PTSD) work by targeting different aspects of the body's stress response. Hydrocortisone, for example, mimics cortisol, a hormone that helps the body recover from stress, potentially reducing PTSD symptoms and promoting resilience. SSRIs and SNRIs increase serotonin and norepinephrine levels in the brain, which can improve mood and reduce anxiety. Prazosin, an alpha-adrenergic receptor blocker, helps reduce nightmares and improve sleep by blocking adrenaline's effects. Understanding these mechanisms is important for PTSD patients as it allows for more personalized and effective treatment strategies.

Find a Location

Who is running the clinical trial?

The Chaim Sheba Medical CenterOTHER
16 Previous Clinical Trials
6,321 Total Patients Enrolled
Rachel YehudaLead Sponsor
James J. Peters Veterans Affairs Medical CenterFED
57 Previous Clinical Trials
2,680 Total Patients Enrolled

Media Library

Hydrocortisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04924166 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Placebo, HCORT
Post-Traumatic Stress Disorder Clinical Trial 2023: Hydrocortisone Highlights & Side Effects. Trial Name: NCT04924166 — Phase 2
Hydrocortisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04924166 — Phase 2
~46 spots leftby Apr 2025