One pill to prevent PTSD? hydrocortisone shows promise after trauma
NCT ID NCT04924166
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
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201 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Mount Sinai Morningside Emergency Department
New York, New York, 10025, United States
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The Chaim Sheba Medical Center
Ramat Gan, Israel
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Other studies related to the condition(s) this trial covers.
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