Clinical trial NCT05213858: Biological Markers for Post-Traumatic Stress Disorder
Official title: Biological Markers for Post-Traumatic Stress Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-01-28
Enrollment: 300
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: correlation between CAPS score and mean heart rate variability
timeFrame: at baseline
Secondary outcomes:
measure: correlation between CAPS score and fronto-limbic connectivity
timeFrame: at baseline
measure: correlation between CAPS score and frontal activity
timeFrame: at baseline
measure: correlation between CAPS score and depression score
timeFrame: at baseline
Other outcomes:
Locations:
city: Ramla
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
affiliation: sagol center for hyperbaric medicine
name: keren doenyas-barak, md
role: PRINCIPAL_INVESTIGATOR
References: