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NCT02033395 Clinical Trial

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

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02033395
Other study ID # SHEBA-13-0910-JZ-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 9, 2014
Last updated January 9, 2014
Start date January 2014

Study information
Verified date January 2014
Source Sheba Medical Center
Contact Eldor Rogev, MD
Phone 972-3-530-3300
Email eldor.rogev@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Chaim Sheba Medical Center Tel Hashomer

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS). 13 months No
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