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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Sheba Medical Center.
Recruitment status was  Recruiting
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

March 3, 2009
September 22, 2011
April 2009
June 2013   (final data collection date for primary outcome measure)
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 ]
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: 4 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00855270 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Single Dose IV Hydrocortisone in Post Traumatic Stress Disorder (PTSD) Prevention
The Efficacy of a Single Dose IV Hydrocortisone Given Within 6 Hours of Exposure to a Traumatic Event in PTSD Prevention

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Post Traumatic Stress Disorder
  • Drug: Placebo
    IV saline will be used as placebo for control
  • 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
  • Placebo Comparator: saline
    An IV injection of saline will be administered to the control group in a double blind, randomized manner.
    Intervention: Drug: Placebo
  • Experimental: Hydrocortisone
    IV hydrocortisone will be given in a double blind random manner as the active treatment group
    Intervention: Drug: Hydrocortisone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2014
June 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years to 65 Years
Yes
Contact: Joseph Zohar, M.D 972-3-5303300 joseph.zohar@sheba.health.gov.il
Israel
 
NCT00855270
SHEBA-09-6884-JZ-CTIL
No
Sheba Medical Center
Sheba Medical Center
  • National Institute of Mental Health (NIMH)
  • Mount Sinai School of Medicine
Principal Investigator: Joseph Zohar, M.D Sheba Medical Center
Sheba Medical Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP