Post-Traumatic Stress DisorderHP-PTSDNCT02402114
Hydrocortisone for Prevention of Post-Traumatic Stress Disorder
A study testing Hydrocortisone in people with Post-Traumatic Stress Disorder, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Hydrocortisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than age 18
- Presenting to ER for treatment of injuries sustained in a violent physical assault
- Assault met DSM-IV "A" criterion (in patient's view, the assault involved or threatened death or serious injury)
- Patient will be discharged home from Emergency Room
Who cannot join
- Intoxicated due to drugs, alcohol or medication at the time they are approached.
- Under arrest or in police custody at the time they are approached.
- No memory of the assault
- Cognitive impairment or psychosis identified by the treating physician or on chart review.
- Patients whose presenting injury is a result of domestic (i.e. injured by a primary caregiver or significant other) or sexual violence
- Under age 18
Show all 15Show fewer
- Not medically stable enough to participate
- Non-English speakers
- Pregnant or nursing women
- Already on steroid treatment
- Immunosuppressed (taking immunosuppressant medication, cancer undergoing active chemotherapy, AIDS, HIV not on HAART therapy)
- Have an active infection identified by the treating physician or on chart review
- Allergy or adverse reaction to hydrocortisone or other corticosteroids
- Diabetic
- On warfarin therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
About this study
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 patient's 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.
Read more
Early research has suggested that enhancing the body's 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 body's 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.
Read the detailed description
Adult subjects will be screened in the Emergency Department (ED) by research associates. If they meet inclusion/exclusion 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 Department's 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 don't.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Hydrocortisone
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Cortef
120 mg Hydrocortisone given orally one time.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subject randomized to this group receives 1 oral dose of Hydrocortisone 120 mg Receives: Drug: Hydrocortisone |
| Placebo | Placebo comparator | Subject randomized to this group will receive an oral sugar/placebo pill that looks similar to the Hydrocortisone pill. Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive PTSD screens
Percentage of patients that are PTSD positive on the PTSD Checklist scores (PCL-S) as per DSM-IV criteria after 6 weeks of enrollment
Measured: 6 weeks
Secondary outcomes (3)
Difference in PCL-S between HT group and placebo groups
Difference in PCL-S based on DSM VI criteria between HT group and placebo groups after 6 weeks of enrollment
Measured: 6 weeks
Positive PTSD screens
Percentage of patients that are PTSD positive on the PTSD Checklist scores (PCL-S) as per DSM-IV criteria after 6 months of enrollment
Measured: 6 months
Difference in PCL-S between HT group and placebo groups
Difference in PCL-S based on DSM VI criteria between HT group and placebo groups after 6 months of enrollment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start2 Feb 2015 (estimated)
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Why it stopped: Never started or submitted to IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Gardner, MD, Albert Einstein Healthcare Network
- Investigators
- James Gardner, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402114
- Sponsor's protocol ID
- HN4712
- Acronym
- HP-PTSD
- Status last verified
- May 2017
- First submitted
- 25 Mar 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrocortisone for Prevention of Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02402114
- Acronym / sponsor ID
- HP-PTSD / HN4712
- Conditions
- Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started or submitted to IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 2 Feb 2015 (estimated)
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's 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 body's 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 body's 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 inclusion/exclusion 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 Department's 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 don't.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: HydrocortisoneSubject randomized to this group receives 1 oral dose of Hydrocortisone 120 mg |
| Placebo | Placebo comparator | Drug: HydrocortisoneSubject randomized to this group will receive an oral sugar/placebo pill that looks similar to the Hydrocortisone pill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than age 18
- Presenting to ER for treatment of injuries sustained in a violent physical assault
- Assault met DSM-IV "A" criterion (in patient's view, the assault involved or threatened death or serious injury)
- Patient will be discharged home from Emergency Room
Key exclusion criteria (15 listed)
- Intoxicated due to drugs, alcohol or medication at the time they are approached.
- Under arrest or in police custody at the time they are approached.
- No memory of the assault
- Cognitive impairment or psychosis identified by the treating physician or on chart review.
- Patients whose presenting injury is a result of domestic (i.e. injured by a primary caregiver or significant other) or sexual violence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneAlso: Cortef120 mg Hydrocortisone given orally one time. | Drug | Intervention, Placebo |
Primary outcome
Positive PTSD screens
Time frame: 6 weeks
Percentage of patients that are PTSD positive on the PTSD Checklist scores (PCL-S) as per DSM-IV criteria after 6 weeks of enrollment
3 secondary outcomes
Difference in PCL-S between HT group and placebo groups
Time frame: 6 weeks
Positive PTSD screens
Time frame: 6 months
Difference in PCL-S between HT group and placebo groups
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Gardner, MD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone in people with Post-Traumatic Stress Disorder, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive PTSD screens (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.