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
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder||Drug: Placebo Drug: Hydrocortisone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: saline
An IV injection of saline will be administered to the control group in a double blind, randomized manner.
IV saline will be used as placebo for control
IV hydrocortisone will be given in a double blind random manner as the active treatment group
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
- 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 ]
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
|Contact: Joseph Zohar, M.Dfirstname.lastname@example.org|
|Sheba Medical Center||Recruiting|
|Contact: Joseph Zohar, M.D. 972-3-5303300 email@example.com|
|Principal Investigator: Joseph Zohar, M.D|
|Principal Investigator:||Joseph Zohar, M.D||Sheba Medical Center|