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NCT04924166 · ClinicalTrials.gov registry record · Phase 2
PTSD Prevention Using Oral Hydrocortisone
A Phase 2 study of PTSD and Acute Stress Disorder, sponsored by Rachel Yehuda.
- Completed
- Registry status
- Phase 2
- Development phase
- 201
- Enrollment target
- 3
- Study locations
NCT04924166: Completed Phase 2 study of PTSD and Acute Stress Disorder, sponsored by Rachel Yehuda.
NCT04924166 is a Phase 2 study of PTSD and Acute Stress Disorder that has completed, run by Rachel Yehuda. The registered enrollment target is 201 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (33% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04924166, a Phase 2 study of PTSD and Acute Stress Disorder, has completed, sponsored by Rachel Yehuda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 201 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
PTSD diagnosis and symptom severity determined by clinical ratings using the Clinician Administered PTSD Scale (CAPS). Total score range from 0 to 80, higher score indicates higher severity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hydrocortisone
Study Locations (3)
New York
- Mount Sinai Morningside Emergency Department - New York
- Icahn School of Medicine at Mount Sinai - New York
Other
- The Chaim Sheba Medical Center - Ramat Gan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2022-01-12 |
| Est. Completion | 2025-07-06 |
| Phase | Phase 2 |
What the finished NCT04924166 record still lists
NCT04924166 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (33% lower).
The record links to 3 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04924166 reports a single indexed study location in New York, Other.
Frequently Asked Questions
What is clinical trial NCT04924166 about?
NCT04924166 is a clinical study titled "PTSD Prevention Using Oral Hydrocortisone". 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 o...
What is the current status of trial NCT04924166?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 201 participants. The study started on 2022-01-12. Estimated completion is 2025-07-06.
What conditions does trial NCT04924166 study?
This clinical trial studies the following conditions: PTSD, Acute Stress Disorder, Trauma-related Stressor.
What interventions are being tested in trial NCT04924166?
The interventions under investigation include: Placebo (DRUG), Hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT04924166?
This trial is sponsored by Rachel Yehuda, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04924166 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTSD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04924166's enrollment target sits among peer trials
201 27th of 154 higher than 128 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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