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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00855270
• Other study ID #: SHEBA-09-6884-JZ-CTIL
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2009
• Last updated: May 22, 2016
• Start date: April 2009
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Sheba Medical Center
• Contact: Joseph Zohar, M.D
• Phone: 972-3-5303300
• Email: joseph.zohar[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Placebo
IV saline will be used as placebo for control
• 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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat-Gan

Sponsors (3)

Lead Sponsor	Collaborator
Sheba Medical Center	Icahn School of Medicine at Mount Sinai, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Israel, 

References & Publications (16)

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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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		13 months	No