Biological Markers for Post-Traumatic Stress Disorder

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

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: keren doenyas-barak, MD; Phone Number: +972544215487; Email: kerendoenyas@gmail.com

Study Locations

• Israel
  • Ramla, Israel, 70300
    • Recruiting
    • Assaf-Harofeh Medical Center
    • Contact: Shai Efrati, MD; Phone Number: 97289779395; Email: hbo@asaf.health.gov.il
    • Contact: keren doenyas-barak, MD; Phone Number: 97289779395; Email: PTSD-hbo@shamir.gov.il
    • Principal Investigator: keren doenyas, MD
    • Principal Investigator: Shai Efrati, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Male combatants aged 20-60 years, with a history of exposure to an apparently life threatening-combat event, with or without PTSD.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between CAPS score and mean heart rate variability	the correlation between CAPS score and mean heart rate variability will be evaluated	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between CAPS score and fronto-limbic connectivity	the correlation between CAPS score and fronto-limbic connectivity will be evaluated using DTI	at baseline
correlation between CAPS score and frontal activity	the correlation between CAPS score and frontal activity will be evaluated using BOLD MRI	at baseline
correlation between CAPS score and depression score	the correlation between CAPS score and depression score will be evaluated using back depression inventory	at baseline

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: keren doenyas-barak, md, sagol center for hyperbaric medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 16, 2022
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 178-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No