Status:
UNKNOWN
Efficacy of Single Dose IV Hydrocortisone in Post Traumatic Stress Disorder (PTSD) Prevention
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Icahn School of Medicine at Mount Sinai
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
21-65 years
Phase:
NA
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 Po...
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 hou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00855270
Start Date
April 1 2009
End Date
December 1 2016
Last Update
May 24 2016
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel