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Corticosteroid
Hydrocortisone for Preventing PTSD
Phase 2
Recruiting
Led By Rachel Yehuda, PhD
Research Sponsored by Rachel Yehuda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight: 99 lb - 242 lbs
Experienced a traumatic event less than 6 hours ago
Must not have
Individuals prescribed a narcotic medication to alleviate acute pain in the ED will not be eligible to participate in the treatment study.
Currently taking oral steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 months
Summary
This trial tests whether a single dose of hydrocortisone (HCORT) can prevent PTSD in highly distressed trauma survivors. HCORT works by boosting the body's natural stress recovery system. If successful, this could provide a simple, portable treatment for those at high risk of PTSD.
Who is the study for?
This trial is for adults who've recently experienced trauma, feel highly distressed or disconnected, and have a heart rate of 80 bpm or more. They must weigh between 99-242 lbs and not be severely injured, intoxicated, pregnant, on steroids or benzodiazepines, nor have certain chronic diseases or mental health conditions.
What is being tested?
The study tests if a single dose of hydrocortisone (HCORT), given within six hours after trauma can prevent PTSD compared to a placebo. It's randomized with assessments at multiple intervals post-treatment to measure the decline in PTSD symptoms and related mental health issues.
What are the potential side effects?
Potential side effects are not detailed but may include those typical of corticosteroids like mood swings, increased blood pressure, sleep problems, weight gain, and elevated blood sugar levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My weight is between 99 and 242 lbs.
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I experienced a traumatic event within the last 6 hours.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not been prescribed narcotics for acute pain in the emergency department.
Select...
I am currently taking oral steroids.
Select...
I am able to understand and agree to the study's procedures.
Select...
I have a severe injury or condition that needed surgery under general anesthesia.
Select...
My weight is between 99 lbs and 242 lbs.
Select...
I do not have conditions like unstable diabetes, heart failure, or active infections.
Select...
I have not taken benzodiazepines since experiencing trauma.
Select...
I lost consciousness for more than 30 minutes due to a recent severe head injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinician Administered PTSD Scale (CAPS)
Secondary study objectives
Change in The Clinical Global Impression - Severity (CGI-S)
Change in the Clinical Global Impression - Improvement (CGI-I)
Montgomery-Asberg Depression Rating Scale (MADRS)
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: HCORTActive Control1 Intervention
180 mg capsule PO
Group II: PlaceboPlacebo Group1 Intervention
matching capsule PO
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Post-Traumatic Stress Disorder (PTSD) work by targeting different aspects of the body's stress response. Hydrocortisone, for example, mimics cortisol, a hormone that helps the body recover from stress, potentially reducing PTSD symptoms and promoting resilience.
SSRIs and SNRIs increase serotonin and norepinephrine levels in the brain, which can improve mood and reduce anxiety. Prazosin, an alpha-adrenergic receptor blocker, helps reduce nightmares and improve sleep by blocking adrenaline's effects.
Understanding these mechanisms is important for PTSD patients as it allows for more personalized and effective treatment strategies.
Find a Location
Who is running the clinical trial?
The Chaim Sheba Medical CenterOTHER
16 Previous Clinical Trials
6,369 Total Patients Enrolled
Rachel YehudaLead Sponsor
James J. Peters Veterans Affairs Medical CenterFED
57 Previous Clinical Trials
2,660 Total Patients Enrolled
Rachel Yehuda, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai; James J. Peters Veterans Affairs Medical Center
2 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: HCORT
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.