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

May 22, 2016 updated by: Sheba Medical Center

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat-Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph Zohar, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Hcort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

National Institute of Mental Health (NIMH)
Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Joseph Zohar, M.D, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 22, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-09-6884-JZ-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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