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Hydrocortisone for Preventing PTSD
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).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not been prescribed narcotics for acute pain in the emergency department.You experienced significant emotional distress during or after a traumatic event, as measured by a questionnaire with a score of 15 or higher.My weight is between 99 and 242 lbs.I live too far to attend follow-up visits without difficulty.I am currently taking oral steroids.I experienced 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).I am able to understand and agree to the study's procedures.I have a severe injury or condition that needed surgery under general anesthesia.My weight is between 99 lbs and 242 lbs.Your resting heart rate is 80 beats per minute or higher.I do not have conditions like unstable diabetes, heart failure, or active infections.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.I am 18 years old or older.You experience a significant level of anxiety, rated at least 4 out of 10 on a scale.I have not taken benzodiazepines since experiencing trauma.I lost consciousness for more than 30 minutes due to a recent severe head injury.
- Group 1: Placebo
- Group 2: HCORT
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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