Posttraumatic Stress DisordersNCT01914861
Cortisol Diurnal Variation and the Risk for Developing Post Traumatic Stress Disorder
An observational study of Posttraumatic Stress Disorders and Cortisol Diurnal Variation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine a possible link between the time of day of exposure to a traumatic event and the risk of developing post-traumatic stress disorder. Clinical and biological correlates will also be examined from this perspective. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorders, Cortisol Diurnal Variation
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Dec 2013
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men/Women, age 21-65, who have arrived at the Chaim Sheba Medical Center ER within six hours of exposure to a traumatic event.
Who may be able to join
- Persons 21-65 years old, who have been exposed to an event meeting the following DSM-IV criterion for Acute Stress Disorder:
- Criteria A.1 and A.2 At least one of Criteria B1-5A.1
- Who provide written, informed consent to participate in the study.
Who cannot join
- 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.
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- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine a possible link between the time of day of exposure to a traumatic event and the risk of developing post-traumatic stress disorder. Clinical and biological correlates will also be examined from this perspective.
- 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 |
|---|---|---|
| Men/Women, 21-65, following exposure to a traumatice event | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Posttraumatic stress disorder
Measured: six months
Secondary outcomes (2)
Biological correlates of post-traumatic stress disorder
Measured: six months
correlation between development of Posttraumatice stress disorder and time of traumatic event
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisordersStudies of the same condition, open and under way.
- 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
- NCT01914861
- Sponsor's protocol ID
- Sheba-0361-13-AJW-CTIL
- Status last verified
- Jul 2013
- First submitted
- 31 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortisol Diurnal Variation and the Risk for Developing Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01914861
- Acronym / sponsor ID
- Sheba-0361-13-AJW-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 2 Aug 2013 (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.
The purpose of this study is to examine a possible link between the time of day of exposure to a traumatic event and the risk of developing post-traumatic stress disorder. Clinical and biological correlates will also be examined from this perspective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men/Women, 21-65, following exposure to a traumatice event | – | – |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men/Women, age 21-65, who have arrived at the Chaim Sheba Medical Center ER within six hours of exposure to a traumatic event.
Key inclusion criteria (3 listed)
- Persons 21-65 years old, who have been exposed to an event meeting the following DSM-IV criterion for Acute Stress Disorder:
- Criteria A.1 and A.2 At least one of Criteria B1-5A.1
- Who provide written, informed consent to participate in the study.
Key exclusion criteria (11 listed)
- 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);
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
Development of Posttraumatic stress disorder
Time frame: six months
2 secondary outcomes
Biological correlates of post-traumatic stress disorder
Time frame: six months
correlation between development of Posttraumatice stress disorder and time of traumatic event
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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 Posttraumatic Stress Disorders and Cortisol Diurnal Variation, 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 11 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 2 Aug 2013. 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 Alzbeta J Wetzler, MD (972-3-530-3300, Alzbeta.JuvenWetzler@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Posttraumatic stress disorder (time frame: six 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 2 Aug 2013.