PTSD Clinical Trial
Official title:
PTSD Prevention Using Oral Hydrocortisone in the Immediate Aftermath of Trauma
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 body's 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 civilian/military 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.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18 years 2. Weight: 99 lb - 242 lbs 3. Experienced a traumatic event less than 6 hours ago Secondary Inclusion Criteria: ED staff note marked anxiety emotional distress and or dissociation in relation to index trauma as assessed by meeting a minimum of 2 out of 4 of the peritraumatic characteristics that have been associated with the development of PTSD below: 1. Anxiety Visual Analog Scale minimum score of 4 on a scale of 0 to 10 2. Peritraumatic dissociation (PDEQ) with a cut-point of 15 (lowest possible score is 10) 3. Peritraumatic distress (Peritraumatic Distress Inventory) (PDI) with a cut-point of 15 (lowest possible score is 0) 4. Heart rate at 80 bpm or more Exclusion Criteria: 1. Severe physical injury as assessed with the Abbreviated Injury Scale (AIS > 2); Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by clinical judgment. 2. Inability to provide informed consent or cooperate with the screening or collection of initial measures. 3. Intoxication to a degree that would interfere with the ability to provide informed consent or high level or intoxication reported at the time of trauma. 4. Moderate to severe head injury associated with current trauma exposure as defined by a loss of consciousness >30 minutes following injury. 5. Medical conditions e.g., Cushing's syndrome, current acute infectious or viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, heart failure. 6. Currently taking oral steroids 7. Use of benzodiazepine within 24 hours of trauma exposure will not be eligible to participate in the study 8. Individuals prescribed a narcotic medication to alleviate acute pain in the ED will not be eligible to participate in the treatment study. 9. Weight below 45kg or above 110 kg (99 lbs - 242 lbs) 10. Pregnancy (a urine pregnancy test will be performed in the ED) 11. Individuals experiencing on-going trauma (i.e., domestic violence). 12. Reported diagnoses of schizophrenia, bipolar I disorder, or other psychotic illness. 13. Current or past history of dementia, amnesia or other cognitive disorder predating trauma exposure 14. Residence outside local area, which would hinder attendance at follow up visits due to long travel time. |
Country | Name | City | State |
---|---|---|---|
Israel | The Chaim Sheba Medical Center | Ramat Gan | |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | Mount Sinai Morningside Emergency Department | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Rachel Yehuda | James J. Peters Veterans Affairs Medical Center, The Chaim Sheba Medical Center |
United States, Israel,
Cohen H, Kaplan Z, Zohar J. [CAN POST-TRAUMATIC STRESS DISORDER BE PREVENTED WITH GLUCOCORTICOIDS?]. Harefuah. 2016 Dec;155(12):757-761. Hebrew. — View Citation
Ozer EJ, Best SR, Lipsey TL, Weiss DS. Predictors of posttraumatic stress disorder and symptoms in adults: a meta-analysis. Psychol Bull. 2003 Jan;129(1):52-73. doi: 10.1037/0033-2909.129.1.52. — View Citation
Yehuda R, Bryant R, Marmar C, Zohar J. Pathological responses to terrorism. Neuropsychopharmacology. 2005 Oct;30(10):1793-805. doi: 10.1038/sj.npp.1300816. — View Citation
Zohar J, Yahalom H, Kozlovsky N, Cwikel-Hamzany S, Matar MA, Kaplan Z, Yehuda R, Cohen H. High dose hydrocortisone immediately after trauma may alter the trajectory of PTSD: interplay between clinical and animal studies. Eur Neuropsychopharmacol. 2011 Nov;21(11):796-809. doi: 10.1016/j.euroneuro.2011.06.001. Epub 2011 Jul 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinician Administered PTSD Scale (CAPS) | PTSD diagnosis and symptom severity determined by clinical ratings using the Clinician Administered PTSD Scale (CAPS). Total score range from 0 to 80, higher score indicates higher severity. | Up to 7 months | |
Secondary | The Structured Clinical Interview for DSM-5 (SCID) | The Structured Clinical Interview for DSM-5 (SCID) assesses the presence of other psychiatric diagnoses and comorbid conditions that can develop in response to trauma exposure, including depression, acute stress disorder and substance use disorder. In addition, participants will complete self-ratings at each time point to assess sleep quality, quality of life, and mood.
This is not a scale. Each is answered as absence or presence of the diagnosis in the past 30 days. |
Up to 7 months | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | Sleep quality is disrupted in PTSD and other mental health problems (e.g., depression). Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Rating scores for PSQI range from 0 to 21. | Up to 7 months | |
Secondary | The Sheehan Disability Scale (SDS) | Functional disability - The Sheehan Disability Scale (SDS) addresses the impact of symptoms of PTSD on work, social, and family functioning within the last 7 days. | Up to 7 months | |
Secondary | Change in The Clinical Global Impression - Severity (CGI-S) | CGI-S rating scores range from 'Normal, not at all ill = 0' to 'Among the most ill patients = 7'. | Baseline and 7 months | |
Secondary | Change in the Clinical Global Impression - Improvement (CGI-I) | CGI-I rating scores range from 'Not assessed = 0' to 'Very much worse = 7' | Baseline and 7 months | |
Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) | Depressive symptoms Clinician ratings of depression will be obtained with the Montgomery-Asberg Depression Rating Scale (MADRS) consisting of 10 items that assess core symptoms of depression. Scores range from 0 to 60, with higher scores indicative of higher depressive symptoms. | Up to 7 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03962504 -
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
|
N/A | |
Completed |
NCT01995123 -
Behavioral Activation for Smoking Cessation in PTSD
|
N/A | |
Not yet recruiting |
NCT06278922 -
Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma
|
N/A | |
Completed |
NCT04597450 -
Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
|
Phase 1 | |
Completed |
NCT03593772 -
Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
|
N/A | |
Completed |
NCT03429166 -
Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
|
N/A | |
Recruiting |
NCT04317820 -
Deep Brain Reorienting in Post-traumatic Stress Disorder
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT03504722 -
Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD
|
N/A | |
Completed |
NCT04305353 -
Intensive Care Unit (ICU) Diary Project
|
N/A | |
Completed |
NCT03113890 -
McLean and Genomind Prospective Study
|
N/A | |
Withdrawn |
NCT05173831 -
Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans
|
Phase 2 | |
Withdrawn |
NCT03924297 -
Chilipad for Sleep and Symptoms of PTSD
|
N/A | |
Not yet recruiting |
NCT04056767 -
Changes in Digital Phenotype During PE Therapy
|
||
Completed |
NCT03158558 -
Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD
|
N/A | |
Withdrawn |
NCT03216356 -
Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD
|
Phase 2/Phase 3 | |
Completed |
NCT03343028 -
Biomarker Establishment for Superior Treatment of PTSD
|
||
Completed |
NCT02370173 -
A Non-Pharmacological Method for Enhancing Sleep in PTSD
|
N/A | |
Withdrawn |
NCT01957371 -
Mindful Yoga Therapy for Veterans With PTSD and Pain
|
N/A | |
Completed |
NCT01955538 -
The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees.
|
Phase 3 |