Hair Cortisol Level as a Predictor of PTSD Development

NCT01804426 | Withdrawn

• 1 other identifier: MMC-12-221
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Post-traumatic stress disorder, PTSD, is one of the most prevalent psychiatric disorders. As casualties of motor vehicle accidents, criminal acts or terrorism are arriving to the ER, it is almost impossible to conclude who will overcome his psychiatric trauma and will be able to return to his normal life course and who will be thrown out of his promising life trajectory. Current attempts to identify those who are at the greatest risk are still unsatisfactory, which comprise a therapeutic dilemma, since the interventions used to ameliorate and prevent the occurrence of PTSD in a high-risk patient, might be counter-productive and even precipitate the emergence of PTSD in lower-risk patients. Since PTSD is closely related to the "Fight, Flight or Freeze" reaction, it has much to do with the autonomic nervous system and the major stress hormone, cortisol. Despite many studies demonstrating the involvement of those factors in the development of PTSD, various attempts to profile the direction of the association between PTSD and cortisol abnormalities have yielded conflicting results. The introduction of a novel method of assessing the excretion of cortisol using residues in the human hair shaft, has allowed an unprecedented evaluation of its activity over a prolonged period of time. Using this novel method of cortisol assessment, the investigators aim to identify biomarkers that will be able to aid in the prediction of PTSD development ahead of symptoms emergence, and will enhance the understanding of the physiological mechanism involved and etiology of this disorder.

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD; Post Traumatic Stress Disorder; Cortisol; Alpha-Amylase; bio-Markers

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in PTSD Symptoms

  Change and development of PTSD symptoms from baseline using validated constructed psychiatric interview (CAPS) and self-administered questionnaire (PSS)

  3, 6, and 12 month post recruitment

Secondary Outcomes (2)

• ASD Development

  1 month

• Change from Baseline in Hair Cortisol Levels

  1, 3, 6 and 12 months post recruitment

Study Arms (1)

Trauma Exposed participants

18-50 years old men and women who have been brought to the ER after being involved or witnessing a life threatening event (or an event which was perceived as such).

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

50 men and women arriving at Meir medical center Emergency department, as a result of a traumatic civil event.

You may qualify if:

• Age 18-50
• Experienced a traumatic event fitting criterion A1 (stressor), A2 (Reaction) and at least 1 out of the B criterion in the ASD criteria in the DSM-IV-TR
• Brought to the ER within hours of the traumatic event.
• Signed an informed consent

You may not qualify if:

• Known psychiatric disorder or current psychiatric medication
• Complex injury or need for a complex medical treatment, such as operation, Packed RBC or admission extending 36 hours.
• Disorientation, confusion, head injury including intra-cranial bleeding, LOC or a major neurological deficit.
• Known disorder of the HPA axis or use of steroidal medications within the previous 3 years.
• known neurological disease or previous brain surgery.
• Major medical conditions or using medication known to influence the HPA or ANS Axis.
• Baldness or hair shorter than 1cm.
• Using color dyes.
• Pregnancy.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Blood * Saliva * Hair

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Michael Lishner, MD, Prof

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatry Resident

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 5, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

IL (1)