HCORT for Post Traumatic Stress Disorder

Phase-Based Progress Estimates
Icahn School of Medicine at Mount Sinai, New York, NYPost Traumatic Stress Disorder+2 MoreHydrocortisone - Drug
All Sexes
What conditions do you have?

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).

Eligible Conditions
  • Post Traumatic Stress Disorder
  • Acute Stress Disorder
  • Trauma-related Stressor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 7 months

Baseline and 7 months
Change in The Clinical Global Impression - Severity (CGI-S)
Change in the Clinical Global Impression - Improvement (CGI-I)
Up to 7 months
Clinician Administered PTSD Scale (CAPS)
Montgomery-Asberg Depression Rating Scale (MADRS)
Pittsburgh Sleep Quality Index (PSQI)
The Sheehan Disability Scale (SDS)
The Structured Clinical Interview for DSM-5 (SCID)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Active Control

Non-Treatment Group

220 Total Participants · 2 Treatment Groups

Primary Treatment: HCORT · Has Placebo Group · Phase 2

ActiveComparator Group · 1 Intervention: Hydrocortisone · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 7 months

Who is running the clinical trial?

Rachel YehudaLead Sponsor
James J. Peters Veterans Affairs Medical CenterFED
53 Previous Clinical Trials
2,786 Total Patients Enrolled
The Chaim Sheba Medical CenterOTHER
15 Previous Clinical Trials
6,303 Total Patients Enrolled
Rachel Yehuda, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai; James J. Peters Veterans Affairs Medical Center
1 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have gone through a traumatic event within the last 6 hours.
The medical team has observed that you are very anxious, upset, or disconnected from reality following a traumatic event. They will evaluate if you meet two or more of the four common symptoms that can lead to post-traumatic stress disorder (PTSD).
You experienced a traumatic event and may have felt disconnected from reality or your own body during or after the event. If you scored above 15 on a specific questionnaire, you may not be eligible for the trial.
You experience a significant level of anxiety, rated at least 4 out of 10 on a scale.
Your resting heart rate is 80 beats per minute or higher.
You experienced significant emotional distress during or after a traumatic event, as measured by a questionnaire with a score of 15 or higher.

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.