Post Traumatic Stress DisorderNCT02033395
A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)
An observational study of Post Traumatic Stress Disorder, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women, age 18-70, who were examined in the ER following a traumatic event.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Chaim Sheba Medical Center
Tel HaShomer, 52621
Eldor Rogev, MD, 972-3-5303300, eldor.rogev@sheba.health.gov.il
Eldor Rogev, MD
About this study
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
- Conditions
- Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants exposed to tramautic event | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS).
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033395
- Sponsor's protocol ID
- SHEBA-13-0910-JZ-CTIL
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02033395
- Acronym / sponsor ID
- SHEBA-13-0910-JZ-CTIL
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants exposed to tramautic event | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women, age 18-70, who were examined in the ER following a traumatic event.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS).
Time frame: 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eldor Rogev, MD (972-3-530-3300, eldor.rogev@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS). (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014; AzTrials last refreshed its copy on 2 Nov 2026.