DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Traumatic Stress Disorder

Intervention: Placebo (Drug); Hydrocortisone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Sheba Medical Center

Official(s) and/or principal investigator(s):
Joseph Zohar, M.D, Principal Investigator, Affiliation: Sheba Medical Center

Overall contact:
Joseph Zohar, M.D, Phone: 972-3-5303300, Email: joseph.zohar@sheba.health.gov.il


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).

Clinical Details

Official title: The Efficacy of a Single Dose IV Hydrocortisone Given Within 6 Hours of Exposure to a Traumatic Event in PTSD Prevention

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: The primary outcome is PTSD diagnosis 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.

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.


Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

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

Sheba Medical Center, Ramat-Gan, Israel; Recruiting
Joseph Zohar, M.D., Phone: 972-3-5303300, Email: joseph.zohar@sheba.health.gov.il
Joseph Zohar, M.D, Principal Investigator
Additional Information

Related publications:

Yehuda R, McFarlane AC, Shalev AY. Predicting the development of posttraumatic stress disorder from the acute response to a traumatic event. Biol Psychiatry. 1998 Dec 15;44(12):1305-13. Review.

Delahanty DL, Raimonde AJ, Spoonster E. Initial posttraumatic urinary cortisol levels predict subsequent PTSD symptoms in motor vehicle accident victims. Biol Psychiatry. 2000 Nov 1;48(9):940-7.

Yehuda R, Yang RK, Buchsbaum MS, Golier JA. Alterations in cortisol negative feedback inhibition as examined using the ACTH response to cortisol administration in PTSD. Psychoneuroendocrinology. 2006 May;31(4):447-51. Epub 2005 Dec 20.

Yehuda R, Brand SR, Golier JA, Yang RK. Clinical correlates of DHEA associated with post-traumatic stress disorder. Acta Psychiatr Scand. 2006 Sep;114(3):187-93.

Morgan CA 3rd, Southwick S, Hazlett G, Rasmusson A, Hoyt G, Zimolo Z, Charney D. Relationships among plasma dehydroepiandrosterone sulfate and cortisol levels, symptoms of dissociation, and objective performance in humans exposed to acute stress. Arch Gen Psychiatry. 2004 Aug;61(8):819-25.

Delahanty DL, Raimonde AJ, Spoonster E, Cullado M. Injury severity, prior trauma history, urinary cortisol levels, and acute PTSD in motor vehicle accident victims. J Anxiety Disord. 2003;17(2):149-64.

Charney DS, Deutch AY, Krystal JH, Southwick SM, Davis M. Psychobiologic mechanisms of posttraumatic stress disorder. Arch Gen Psychiatry. 1993 Apr;50(4):295-305. Review.

Schelling G, Briegel J, Roozendaal B, Stoll C, Rothenhäusler HB, Kapfhammer HP. The effect of stress doses of hydrocortisone during septic shock on posttraumatic stress disorder in survivors. Biol Psychiatry. 2001 Dec 15;50(12):978-85.

Schelling G. Effects of stress hormones on traumatic memory formation and the development of posttraumatic stress disorder in critically ill patients. Neurobiol Learn Mem. 2002 Nov;78(3):596-609.

Schelling G, Kilger E, Roozendaal B, de Quervain DJ, Briegel J, Dagge A, Rothenhäusler HB, Krauseneck T, Nollert G, Kapfhammer HP. Stress doses of hydrocortisone, traumatic memories, and symptoms of posttraumatic stress disorder in patients after cardiac surgery: a randomized study. Biol Psychiatry. 2004 Mar 15;55(6):627-33.

Schelling G, Roozendaal B, Krauseneck T, Schmoelz M, DE Quervain D, Briegel J. Efficacy of hydrocortisone in preventing posttraumatic stress disorder following critical illness and major surgery. Ann N Y Acad Sci. 2006 Jul;1071:46-53. Review.

Lupien SJ, Maheu F, Tu M, Fiocco A, Schramek TE. The effects of stress and stress hormones on human cognition: Implications for the field of brain and cognition. Brain Cogn. 2007 Dec;65(3):209-37. Epub 2007 Apr 26. Review.

Harvey BH, Brand L, Jeeva Z, Stein DJ. Cortical/hippocampal monoamines, HPA-axis changes and aversive behavior following stress and restress in an animal model of post-traumatic stress disorder. Physiol Behav. 2006 May 30;87(5):881-90. Epub 2006 Mar 6.

Cohen H, Zohar J, Gidron Y, Matar MA, Belkind D, Loewenthal U, Kozlovsky N, Kaplan Z. Blunted HPA axis response to stress influences susceptibility to posttraumatic stress response in rats. Biol Psychiatry. 2006 Jun 15;59(12):1208-18. Epub 2006 Feb 3.

Cohen H, Zohar J. An animal model of posttraumatic stress disorder: the use of cut-off behavioral criteria. Ann N Y Acad Sci. 2004 Dec;1032:167-78. Review.

Cohen H, Matar MA, Buskila D, Kaplan Z, Zohar J. Early post-stressor intervention with high-dose corticosterone attenuates posttraumatic stress response in an animal model of posttraumatic stress disorder. Biol Psychiatry. 2008 Oct 15;64(8):708-17. doi: 10.1016/j.biopsych.2008.05.025. Epub 2008 Jul 17.

Starting date: April 2009
Last updated: September 22, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017