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A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)

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ClinicalTrials.gov Identifier: NCT02033395
Recruitment Status : Unknown
Verified January 2014 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

This observational study follows subjects who have been exposed to a traumatic event and are at risk of developing PTSD symptoms. Participants are recruited within six hours of a traumatic event, and, starting from the recruitment session, are then examined on six set points of time within a period of thirteen months. The examinations include both biological studies of cortisol in hair, blood and saliva, and psychological examinations and questionaires that assess the development and severity of PTSD symptoms.

The novel method of sampling hair cortisol allows investigators to retroactively estimate the mean levels of blood cortisol during the tree months prior to the sampling.

The study aims at further illuminating the correlation between cortisol levels both prior and following a traumatic event, and the development and severity of PTSD symptoms


Condition or disease
Post Traumatic Stress Disorder

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016


Group/Cohort
Participants exposed to tramautic event



Primary Outcome Measures :
  1. PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS). [ Time Frame: 13 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women, age 18-70, who were examined in the ER following a traumatic event.
Criteria

Inclusion Criteria:

  • Age 18-70.
  • Experienced a traumatic and were at risk (or perceived risk) of serious injury to themselves or others in their surroundings.
  • Signed an informed consent form.

Exclusion Criteria:

  • Age under 18 or over 70.
  • Severe or complex physical injury, such as severe head trauma, massive burns or injuries that require surgery under full anesthesia.
  • A personal history of Psychotic state or PTSD.
  • Pregnancy
  • Weight below 45 Kg or over 120 Kg.
  • Hair shorter than 1.5 cm.

Information from the National Library of Medicine

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): NCT02033395


Contacts
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Contact: Eldor Rogev, MD 972-3-530-3300 eldor.rogev@sheba.health.gov.il

Locations
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Israel
Chaim Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 52621
Contact: Eldor Rogev, MD    972-3-5303300    eldor.rogev@sheba.health.gov.il   
Sub-Investigator: Eldor Rogev, MD         
Principal Investigator: Joseph Zohar, MD         
Sponsors and Collaborators
Sheba Medical Center

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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02033395     History of Changes
Other Study ID Numbers: SHEBA-13-0910-JZ-CTIL
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Hydrocortisone
Anti-Inflammatory Agents