Skip to content

Cortisol Diurnal Variation and the Risk for Developing Post Traumatic Stress Disorder

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01914861
Enrollment
60
Registered
2013-08-02
Start date
2013-07-31
Completion date
Unknown
Last updated
2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cortisol Diurnal Variation, Posttraumatic Stress Disorders

Brief 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.

Interventions

None listed

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. 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 2. Who provide written, informed consent to participate in the study.

Exclusion criteria

1. 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; 2. Head injury involving confusion, loss of consciousness, or amnesia; 3. 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; 4. Weight below 45 or above 120 kg. 5. Pregnancy (in suggestive cases, a pregnancy test will be performed); 6. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period. 7. Overt psychopathology, intoxication, or under the influence of substances. 8. Evidence or history of schizophrenia, bipolar, other psychotic condition; 9. Prior history of PTSD; 10. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure; 11. Assessed serious suicide risk. -

Design outcomes

Primary

MeasureTime frame
Development of Posttraumatic stress disordersix months

Secondary

MeasureTime frame
Biological correlates of post-traumatic stress disordersix months
correlation between development of Posttraumatice stress disorder and time of traumatic eventsix months

Countries

Israel

Contacts

Primary ContactAlzbeta J Wetzler, MD
Alzbeta.JuvenWetzler@sheba.health.gov.il972-3-530-3300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026