Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924166
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2021-06-07
Brief Title:
PTSD Prevention Using Oral Hydrocortisone
Sponsor:
Rachel Yehuda
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
PTSD Prevention Using Oral Hydrocortisone in the Immediate Aftermath of Trauma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bodys 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 civilianmilitary 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
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 civilianmilitary 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
Detailed Description:
Preliminary findings using HCORT in PTSD prevention have been encouraging However it is imperative to provide a more definitive study of HCORT effects across a wide range of demographic and traumatic exposures In addition prior studies used a single IV dose of HCORT administered in the Emergency Department ED and it is critical to determine whether effects would be comparable using oral HCORT The advantage of an oral prophylactic is that a pill is a portable prophylactic that could be carried by first responders military personnel and other people whose occupations expose them to risk of trauma exposure
The results of this RCT will add to the existing literature in several important ways The study will be larger in scope and will target a more extensive biological profile to elucidate mechanisms of action To maximize enrollment within a shorter period of time the study will be conducted at two sites The first site is the ED at the Mount Sinai Hospital located in East Harlem in New York City NYC and the second is the ED at Sheba Medical Center in Israel These sites allow for the evaluation of a broad range of trauma survivors In NYC the large urban ED provides services to a diverse population with respect to race ethnicity and trauma exposure At Sheba Medical Center those who present to the ED are active duty reserve military personnel and civilians By including both sites the investigators will be able to evaluate the effectiveness of the intervention in a global and more ethnically diverse sample that includes people exposed to a wide variety of traumas Prior research and results from the researchers intervention studies indicate the importance of recruiting participants who are distressed including those expressing feelings of dissociation when they present to the ED ie such people are at greater risk for the development of PTSD following trauma exposure that is life-threatening or causes injury For this reason the current study will select participants who meet a specified threshold for acute distress following trauma exposure
There is accumulating evidence to support the potential mechanism of action of the administration of HCORT on achieving homeostasis and resilience following exposure to a critical traumatic incident In this interventional study the researchers will collect blood samples for the purpose of conducting further analyses of biomarkers to obtain more information about the mechanisms of action of this intervention and to enhance knowledge about mechanisms associated with resilience These aims will be achieved by assessing candidate neuroendocrine biomarkers as well as related molecular networks eg genome wide methylation and expression relevant to PTSD risk and resilience
If the current trial using oral administration of HCORT is successful it will generate a viable safe portable lightweight prophylactic treatment that can be self-administered and made available to military personnel first responders and other civilians exposed to extreme trauma
The results of this RCT will add to the existing literature in several important ways The study will be larger in scope and will target a more extensive biological profile to elucidate mechanisms of action To maximize enrollment within a shorter period of time the study will be conducted at two sites The first site is the ED at the Mount Sinai Hospital located in East Harlem in New York City NYC and the second is the ED at Sheba Medical Center in Israel These sites allow for the evaluation of a broad range of trauma survivors In NYC the large urban ED provides services to a diverse population with respect to race ethnicity and trauma exposure At Sheba Medical Center those who present to the ED are active duty reserve military personnel and civilians By including both sites the investigators will be able to evaluate the effectiveness of the intervention in a global and more ethnically diverse sample that includes people exposed to a wide variety of traumas Prior research and results from the researchers intervention studies indicate the importance of recruiting participants who are distressed including those expressing feelings of dissociation when they present to the ED ie such people are at greater risk for the development of PTSD following trauma exposure that is life-threatening or causes injury For this reason the current study will select participants who meet a specified threshold for acute distress following trauma exposure
There is accumulating evidence to support the potential mechanism of action of the administration of HCORT on achieving homeostasis and resilience following exposure to a critical traumatic incident In this interventional study the researchers will collect blood samples for the purpose of conducting further analyses of biomarkers to obtain more information about the mechanisms of action of this intervention and to enhance knowledge about mechanisms associated with resilience These aims will be achieved by assessing candidate neuroendocrine biomarkers as well as related molecular networks eg genome wide methylation and expression relevant to PTSD risk and resilience
If the current trial using oral administration of HCORT is successful it will generate a viable safe portable lightweight prophylactic treatment that can be self-administered and made available to military personnel first responders and other civilians exposed to extreme trauma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH1910138 | OTHER_GRANT | Department of Defense | None |