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

NCT00855270 | Unknown

• 1 other identifier: SHEBA-09-6884-JZ-CTIL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

saline

PLACEBO COMPARATOR

An IV injection of saline will be administered to the control group in a double blind, randomized manner.

Drug: Placebo

Hydrocortisone

EXPERIMENTAL

IV hydrocortisone will be given in a double blind random manner as the active treatment group

Drug: Hydrocortisone

Interventions

Placebo DRUG

IV saline will be used as placebo for control

saline

Hydrocortisone DRUG

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.

Also known as: Hcort

Hydrocortisone

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related Publications (21)

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  PMID: 38767196 DERIVED

• Carmi L, Zohar J, Juven-Wetzler A, Desarnaud F, Makotkine L, Bierer LM, Cohen H, Yehuda R. Promoter methylation of the glucocorticoid receptor following trauma may be associated with subsequent development of PTSD. World J Biol Psychiatry. 2023 Sep-Oct;24(7):578-586. doi: 10.1080/15622975.2023.2177342. Epub 2023 Mar 13.

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• Carmi L, Zohar J, Weissman T, Juven-Wetzler A, Bierer L, Yehuda R, Cohen H. Hydrocortisone in the emergency department: a prospective, double-blind, randomized, controlled posttraumatic stress disorder study. Hydrocortisone during golden hours. CNS Spectr. 2023 Aug;28(4):457-463. doi: 10.1017/S1092852922000852. Epub 2022 Jun 9.

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  PMID: 35141873 DERIVED

• Zohar J, Yahalom H, Kozlovsky N, Cwikel-Hamzany S, Matar MA, Kaplan Z, Yehuda R, Cohen H. High dose hydrocortisone immediately after trauma may alter the trajectory of PTSD: interplay between clinical and animal studies. Eur Neuropsychopharmacol. 2011 Nov;21(11):796-809. doi: 10.1016/j.euroneuro.2011.06.001. Epub 2011 Jul 8.

  PMID: 21741804 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Joseph Zohar, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Zohar, M.D

CONTACT

972-3-5303300; joseph.zohar@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

IL (1)