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

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ClinicalTrials.gov Identifier: NCT00855270
Recruitment Status : Unknown
Verified May 2016 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : March 4, 2009
Last Update Posted : May 24, 2016
National Institute of Mental Health (NIMH)
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: Placebo Drug: Hydrocortisone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2009
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The primary outcome is symptom severity 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855270

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

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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
National Institute of Mental Health (NIMH)
Icahn School of Medicine at Mount Sinai
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Principal Investigator: Joseph Zohar, M.D Sheba Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00855270    
Other Study ID Numbers: SHEBA-09-6884-JZ-CTIL
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Keywords provided by Sheba Medical Center:
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Anti-Inflammatory Agents