Study 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).
- Post Traumatic Stress Disorder
- Acute Stress Disorder
- Trauma-related Stressor
Treatment Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Up to 7 months
Trial Safety
Trial Design
2 Treatment Groups
HCORT
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group
220 Total Participants · 2 Treatment Groups
Primary Treatment: HCORT · Has Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Auxéméry, Y.. 2012. “L’état de stress post-traumatique comme conséquence de l’interaction entre une susceptibilité génétique individuelle, un évènement traumatogène et un contexte social”. L'encéphale. Elsevier BV. doi:10.1016/j.encep.2011.12.003.
- Ozer, Emily J., Suzanne R. Best, Tami L. Lipsey, and Daniel S. Weiss. 2003. “Predictors of Posttraumatic Stress Disorder and Symptoms in Adults: A Meta-analysis.”. Psychological Bulletin. American Psychological Association (APA). doi:10.1037/0033-2909.129.1.52.
- Yehuda, Rachel, Richard Bryant, Charles Marmar, and Joseph Zohar. 2005. “Pathological Responses to Terrorism”. Neuropsychopharmacology. Springer Science and Business Media LLC. doi:10.1038/sj.npp.1300816.
- Zohar, Joseph, Hila Yahalom, Nitsan Kozlovsky, Shlomit Cwikel-Hamzany, Michael A. Matar, Zeev Kaplan, Rachel Yehuda, and Hagit Cohen. 2011. “High Dose Hydrocortisone Immediately After Trauma May Alter the Trajectory of PTSD: Interplay Between Clinical and Animal Studies”. European Neuropsychopharmacology. Elsevier BV. doi:10.1016/j.euroneuro.2011.06.001.
- Zohar, Joseph, Hila Yahalom, Nitsan Kozlovsky, Shlomit Cwikel-Hamzany, Michael A. Matar, Zeev Kaplan, Rachel Yehuda, and Hagit Cohen. 2011. “High Dose Hydrocortisone Immediately After Trauma May Alter the Trajectory of PTSD: Interplay Between Clinical and Animal Studies”. European Neuropsychopharmacology. Elsevier BV. doi:10.1016/j.euroneuro.2011.06.001.
- Cohen H, Kaplan Z, Zohar J. [CAN POST-TRAUMATIC STRESS DISORDER BE PREVENTED WITH GLUCOCORTICOIDS?]. Harefuah. 2016 Dec;155(12):757-761. Hebrew.
- Yehuda R, Bryant R, Marmar C, Zohar J. Pathological responses to terrorism. Neuropsychopharmacology. 2005 Oct;30(10):1793-805. doi: 10.1038/sj.npp.1300816.
- Ozer EJ, Best SR, Lipsey TL, Weiss DS. Predictors of posttraumatic stress disorder and symptoms in adults: a meta-analysis. Psychol Bull. 2003 Jan;129(1):52-73. doi: 10.1037/0033-2909.129.1.52.
- Rachel Yehuda 2021. "PTSD Prevention Using Oral Hydrocortisone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04924166.
Frequently Asked Questions
Is this study still recruiting patients?
"The clinical trial is still recruiting patients, based on the information available from clinicaltrials.gov. The first posting for this trial was on September 23rd, 2021 with the most recent edit taking place on December 27th, 2021." - Anonymous Online Contributor
What is the official stance of the FDA on HCORT?
"While there is some evidence of HCORT's safety, it is still in Phase 2 clinical trials and has not been proven effective yet." - Anonymous Online Contributor
Yes, our team has conducted several Phase III clinical trials with HCORT.
"There are 63 ongoing studies investigating the efficacy of HCORT. 20 of these trials have progressed to Phase 3 clinical testing. While New York, New York has the most active trials for this treatment, there are a total 3040 locations running studies related to HCORT across the globe." - Anonymous Online Contributor
For what reasons is HCORT often recommended?
"HCORT is a medication that's typically given to patients suffering from ulcerative colitis. However, it has also shown efficacy in the treatment of other conditions like malignant neoplasms, varicella-zoster virus acute retinal necrosis, and crohn disease." - Anonymous Online Contributor
How many individuals are receiving this therapy?
"That is correct. The clinical trial is still recruiting patients, as of 12/27/2021. If you go to the website clinicaltrials.gov, you can find that the trial was first posted on 9/23/2021. They are looking for 220 participants total at 1 location currently." - Anonymous Online Contributor