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One pill to prevent PTSD? hydrocortisone shows promise after trauma

NCT ID NCT04924166

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a single dose of hydrocortisone, given within 6 hours of a traumatic event, could prevent PTSD. 201 trauma survivors from two hospitals received either hydrocortisone or a placebo. Researchers tracked their mental health for 28 weeks to see if the drug reduced PTSD symptoms and boosted recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydrocortisone
What this could lead to
If it works, this could provide a simple, one-time treatment to prevent PTSD after a traumatic event.
What could go wrong
This is a Phase 2 trial with 201 participants, so results are still early. The effect may be small or not apply to everyone, and side effects from a single high dose of hydrocortisone are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

201 people

The number who actually took part.

Started

Jan 2022

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Mount Sinai Morningside Emergency Department

    New York, New York, 10025, United States

  • The Chaim Sheba Medical Center

    Ramat Gan, Israel

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