Ignite Creation Date:
2024-05-06 @ 3:55 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02402114
Status:
WITHDRAWN
Last Update Posted:
2017-05-10
First Post:
2015-03-25
Brief Title:
Hydrocortisone for Prevention of Post-Traumatic Stress Disorder
Sponsor:
Albert Einstein Healthcare Network
Organization:
Albert Einstein Healthcare Network
Study Overview
Official Title:
Hydrocortisone for Prevention of Post-Traumatic Stress Disorder
Status:
WITHDRAWN
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never started or submitted to IRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HP-PTSD
Brief Summary:
Post-Traumatic Stress Disorder PTSD is an acquired psychiatric condition that occurs after exposure to a dangerous or life-threatening event It is characterized by persistent fear- and stress-related symptoms such as nightmares flashbacks depression anxiety and guilt These symptoms can interfere significantly with patients lives and in some cases can be debilitating One of the most frequent causes of PTSD is being a victim of a violent interpersonal assault
PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded too strongly in a patients long-term memory remaining too accessible and present to the patient long after the actual threat has passed In recent years evidence has emerged that it may be possible to prevent PTSD by moderating the process of memory consolidation that occurs in the hours and days after a traumatic event
Early research has suggested that enhancing the bodys natural cortisol response to a stressful event may be a safe and effective way of moderating the process of memory consolidation and promoting adaptive non-pathological memory encoding In particular the administration of hydrocortisone a safe and widely used drug that mimics the bodys own cortisol hormone appears to reduce the risk of developing PTSD in patients who have sustained a traumatic event However this research is still in relatively early stages and requires larger trials to confirm its efficacy In addition the research thus far has not adequately targeted assault victims whom Investigator feel are some of the patients most likely to benefit from such an approach
Investigators propose a prospective placebo-controlled double-blinded trial of administering single-dose oral hydrocortisone or placebo to 100 assault victims seen in the Einstein Medical Center Philadelphia Emergency Department to determine if this approach has efficacy in preventing PTSD This study is designed as a pilot study with the hopes that the data gathered in it can be used to design a larger and more robust trial in the future
PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded too strongly in a patients long-term memory remaining too accessible and present to the patient long after the actual threat has passed In recent years evidence has emerged that it may be possible to prevent PTSD by moderating the process of memory consolidation that occurs in the hours and days after a traumatic event
Early research has suggested that enhancing the bodys natural cortisol response to a stressful event may be a safe and effective way of moderating the process of memory consolidation and promoting adaptive non-pathological memory encoding In particular the administration of hydrocortisone a safe and widely used drug that mimics the bodys own cortisol hormone appears to reduce the risk of developing PTSD in patients who have sustained a traumatic event However this research is still in relatively early stages and requires larger trials to confirm its efficacy In addition the research thus far has not adequately targeted assault victims whom Investigator feel are some of the patients most likely to benefit from such an approach
Investigators propose a prospective placebo-controlled double-blinded trial of administering single-dose oral hydrocortisone or placebo to 100 assault victims seen in the Einstein Medical Center Philadelphia Emergency Department to determine if this approach has efficacy in preventing PTSD This study is designed as a pilot study with the hopes that the data gathered in it can be used to design a larger and more robust trial in the future
Detailed Description:
Adult subjects will be screened in the Emergency Department ED by research associates If they meet inclusionexclusion criteria they will be offered enrollment Subjects who choose to enroll will be randomized to receive either hydrocortisone 120mg PO or placebo PO one time in the Emergency Department They will be given a packet of general information on traumatic stress and contact information for psychiatric assistance if they require it but no further PTSD treatment will be given Any further medical treatment will be at the discretion of the treating team
At 6 weeks after enrollment subjects will be contacted by phone and a brief structured interview based on the PCL-S a well-validated screening instrument for PTSD will be administered by phone Participants who screen positive will be informed that they may be suffering from PTSD and will be offered the opportunity to seek care with the Einstein Psychiatry Departments PTSD program
At 6 months after enrollment subjects will again be contacted and administered the PCL-C as well as questions regarding other psychiatric comorbidities substance use and involvement in any further episodes of violence In addition review of subject medical records over the year since injury will be undertaken to determine if there is any difference in subsequent health-care utilization between those who received hydrocortisone vs placebo and between those who screen positive for PTSD vs those who dont
At 6 weeks after enrollment subjects will be contacted by phone and a brief structured interview based on the PCL-S a well-validated screening instrument for PTSD will be administered by phone Participants who screen positive will be informed that they may be suffering from PTSD and will be offered the opportunity to seek care with the Einstein Psychiatry Departments PTSD program
At 6 months after enrollment subjects will again be contacted and administered the PCL-C as well as questions regarding other psychiatric comorbidities substance use and involvement in any further episodes of violence In addition review of subject medical records over the year since injury will be undertaken to determine if there is any difference in subsequent health-care utilization between those who received hydrocortisone vs placebo and between those who screen positive for PTSD vs those who dont
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None