Efficacy of Single Dose IV Hydrocortisone in Post Traumatic Stress Disorder (PTSD) Prevention

This study is currently recruiting participants.
Verified September 2011 by Sheba Medical Center
Sponsor:
Collaborators:
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00855270
First received: March 3, 2009
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

This study is designed to test the hypothesis that a single Hydrocortisone intra venous injection within 6 hours post-trauma facilitates physiological recovery thereby preventing the development of Post Traumatic Stress Disorder (PTSD) in the months following the event. In the absence of such treatment (i.e., under placebo conditions), we hypothesize that a greater proportion of persons would develop PTSD (i.e., fail to recover from acute effects).


Condition Intervention
Post Traumatic Stress Disorder
Drug: Placebo
Drug: Hydrocortisone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of a Single Dose IV Hydrocortisone Given Within 6 Hours of Exposure to a Traumatic Event in PTSD Prevention

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • The primary outcome is PTSD diagnosis at the end of the trial .This will be determined using the Clinician Administered PTSD Scale (CAPS), a scale with established reliability and good psychometric properties. [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline
An IV injection of saline will be administered to the control group in a double blind, randomized manner.
Drug: Placebo
IV saline will be used as placebo for control
Experimental: Hydrocortisone
IV hydrocortisone will be given in a double blind random manner as the active treatment group
Drug: Hydrocortisone
A single dose 90-150mg of Intra Venous Hydrocortisone. 90mg will be administrated to participants weighing 45-59kg. 100mg will be administrated to participants weighing 60-69kg. 120mg will be administrated to participants weighing 70-89kg. 140mg will be administrated to participants weighing 90-99kg. 150mg will be administrated to participants weighing 100-120kg.
Other Name: Hcort

Detailed Description:

This is a double-blind, placebo-controlled trial in which trauma victims are randomized to receive a single intravenous injection of either Hydrocortisone (90-150mg)or placebo within the first six hours following trauma exposure. To provide a pre-treatment baseline, participants will receive a medical and psychological evaluation prior to treatment. After two weeks the research assistant or study psychiatrist will perform behavioral ratings and complete history details pertaining to PTSD risk factors. Participants will be assessed again by the study psychiatrist or research assistants at 1, 3, 8 & 13 months. Eligible subjects will include men and women over the age of 21, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure, and who provide written, informed consent to participate in the study. In order to recruit persons who are more likely to be at risk for the development of PTSD, we will only randomize persons expressing marked anxiety, emotional distress or dissociation, as assessed by the Visual Analog Scales. Potential participants will be recruited from trauma victims arriving at the Chaim Sheba Medical Center Emergency Room.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Persons over the age of 21, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure, expressing marked anxiety, and/ or emotional distress and/or dissociation, as assessed by the Visual Analog Scales
  2. Who provide written, informed consent to participate in the study.

Exclusion Criteria:

  1. Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by Abbreviated Injury Scale (AIS), or by clinical judgment;
  2. Head injury involving confusion, loss of consciousness, or amnesia;
  3. Medical conditions such as extreme obesity, psoriasis, herpes, Cushing's syndrome, current infectious disease, current viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, and heart failure. Persons taking medications that can interfere with the HPA axis (e.g.,steroids, betablockers,indomethacin) will be excluded;
  4. Weight below 45 or above 120 kg.
  5. Pregnancy (in suggestive cases, a pregnancy test will be performed);
  6. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
  7. Overt psychopathology, intoxication, or under the influence of substances.
  8. Evidence or history of schizophrenia, bipolar, other psychotic condition;
  9. Prior history of PTSD;
  10. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
  11. Assessed serious suicide risk.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855270

Contacts
Contact: Joseph Zohar, M.D 972-3-5303300 joseph.zohar@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Joseph Zohar, M.D.    972-3-5303300    joseph.zohar@sheba.health.gov.il   
Principal Investigator: Joseph Zohar, M.D         
Sponsors and Collaborators
Sheba Medical Center
Mount Sinai School of Medicine
Investigators
Principal Investigator: Joseph Zohar, M.D Sheba Medical Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00855270     History of Changes
Other Study ID Numbers: SHEBA-09-6884-JZ-CTIL
Study First Received: March 3, 2009
Last Updated: September 22, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on April 21, 2014