Efficacy of Single Dose IV Hydrocortisone in Post Traumatic Stress Disorder (PTSD) Prevention
Primary Purpose
Post Traumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Placebo
Hydrocortisone
Sponsored by
About this trial
This is an interventional prevention trial for Post Traumatic Stress Disorder focused on measuring PTSD
Eligibility Criteria
Inclusion Criteria:
- 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
- Who provide written, informed consent to participate in the study.
Exclusion Criteria:
- 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;
- Head injury involving confusion, loss of consciousness, or amnesia;
- 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;
- Weight below 45 or above 120 kg.
- Pregnancy (in suggestive cases, a pregnancy test will be performed);
- Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
- Overt psychopathology, intoxication, or under the influence of substances.
- Evidence or history of schizophrenia, bipolar, other psychotic condition;
- Prior history of PTSD;
- Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
- Assessed serious suicide risk.
Sites / Locations
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
saline
Hydrocortisone
Arm Description
An IV injection of saline will be administered to the control group in a double blind, randomized manner.
IV hydrocortisone will be given in a double blind random manner as the active treatment group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00855270
First Posted
March 3, 2009
Last Updated
May 22, 2016
Sponsor
Sheba Medical Center
Collaborators
National Institute of Mental Health (NIMH), Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT00855270
Brief Title
Efficacy of Single Dose IV Hydrocortisone in Post Traumatic Stress Disorder (PTSD) 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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
National Institute of Mental Health (NIMH), Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
PTSD
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
An IV injection of saline will be administered to the control group in a double blind, randomized manner.
Arm Title
Hydrocortisone
Arm Type
Experimental
Arm Description
IV hydrocortisone will be given in a double blind random manner as the active treatment group
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV saline will be used as placebo for control
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
Hcort
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Who provide written, informed consent to participate in the study.
Exclusion Criteria:
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;
Head injury involving confusion, loss of consciousness, or amnesia;
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;
Weight below 45 or above 120 kg.
Pregnancy (in suggestive cases, a pregnancy test will be performed);
Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
Overt psychopathology, intoxication, or under the influence of substances.
Evidence or history of schizophrenia, bipolar, other psychotic condition;
Prior history of PTSD;
Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
Assessed serious suicide risk.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Zohar, M.D
Phone
972-3-5303300
Email
joseph.zohar@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Zohar, M.D
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat-Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Zohar, M.D.
Phone
972-3-5303300
Email
joseph.zohar@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Joseph Zohar, M.D
12. IPD Sharing Statement
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Efficacy of Single Dose IV Hydrocortisone in Post Traumatic Stress Disorder (PTSD) Prevention
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