Biological Markers for Post-Traumatic Stress Disorder

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05213858
Collaborator
(none)
300
Enrollment
1
Location
24
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The current study aims to evaluate the sensitivity and specificity of a combination of various objective biomarkers for the diagnosis of PTSD.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: CAPS questionnaire
  • Diagnostic Test: Beck Depression Inventory
  • Diagnostic Test: The Fibromyalgia Impact Questionnaire
  • Diagnostic Test: The Pittsburgh Sleep Quality Index
  • Diagnostic Test: Depression, Anxiety and Stress Scale-21 items
  • Diagnostic Test: Traumatic Events Questionnaire
  • Diagnostic Test: Clinician Administered Dissociative States Scale
  • Diagnostic Test: A diary will be used for seven consecutive nights
  • Diagnostic Test: MRI
  • Diagnostic Test: Functional brain imaging
  • Diagnostic Test: EEG analysis
  • Diagnostic Test: Autonomic nervous system monitors

Detailed Description

PTSD affects a major fraction of military combatants and is also very common in the general population. Like other psychiatric conditions, the diagnosis of PTSD is currently based on an interview and questionnaires. However, the validity of these tools is limited since it depends on the evaluator's skills, and on patient compliance and mental status; and may be prone to exaggeration or minimization of symptoms. This prompts an urgent need for evaluation that will combine biomarkers for objective diagnosis, and follow up of individuals with PTSD.

Knowledge has grown in recent years regarding the biologic pathophysiological cascade responsible for the development of a "non-healing wound in the brain" that characterizes PTSD. Shortly after the traumatic experience, fundamental changes in autonomic nervous and endocrine activity are evident, together with changes in brain function; these can become chronic in those with long-standing unremitting PTSD. Several studies indicate good correlations of the diagnosis and severity of PTSD, with objective biological measures such as heart rate variability (HRV), brain connectivity and endocrine activity. However, the currently available data on these biological variables are still not sufficient to be used for diagnosis of PTSD.

The aim of the current study is to characterize the biological fingerprint of PTSD, by using a combination of biological measures, for an objective diagnosis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Biological Markers for Post-Traumatic Stress Disorder
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  1. correlation between CAPS score and mean heart rate variability [at baseline]

    the correlation between CAPS score and mean heart rate variability will be evaluated

Secondary Outcome Measures

  1. correlation between CAPS score and fronto-limbic connectivity [at baseline]

    the correlation between CAPS score and fronto-limbic connectivity will be evaluated using DTI

  2. correlation between CAPS score and frontal activity [at baseline]

    the correlation between CAPS score and frontal activity will be evaluated using BOLD MRI

  3. correlation between CAPS score and depression score [at baseline]

    the correlation between CAPS score and depression score will be evaluated using back depression inventory

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. The willingness and ability to read, understand and sign an informed consent form.

  2. Age 20-60 years.

  3. A history of more than 2 years of combat service, and of at least one potentially life-threatening combat experience.

  4. One year or more after the last combat experience.

Exclusion Criteria:
  1. Inability to attend scheduled clinic visits or comply with the study protocol

  2. A history of traumatic brain injury or any other known brain pathology.

  3. Substance use, except for prescribed cannabis, if it can be withheld for at least 24 hours prior to the study evaluation.

  4. A current psychiatric disorder other than PTSD.

  5. The inability to perform an awake brain MRI.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Assaf-Harofeh Medical CenterRamlaIsrael70300

Sponsors and Collaborators

  • Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: keren doenyas-barak, md, sagol center for hyperbaric medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT05213858
Other Study ID Numbers:
  • 178-21
First Posted:
Jan 28, 2022
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2022