Evaluating biological markers for diagnosing PTSD

Biological Markers for Post-Traumatic Stress Disorder

This study is testing if certain biological markers can help doctors diagnose PTSD more accurately for both military personnel and the general public.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 20 Years to 60 Years
• Sex: Male
• Sponsor: Assaf-Harofeh Medical Center (other gov)
• Locations: 1 site (Ramla)
• Trial ID: NCT05213858 on ClinicalTrials.gov

What this trial studies

This study aims to assess the sensitivity and specificity of various objective biomarkers for diagnosing Post-Traumatic Stress Disorder (PTSD). PTSD is prevalent among military personnel and the general population, yet current diagnostic methods rely heavily on subjective interviews and questionnaires, which can be unreliable. By combining biological measures such as heart rate variability and brain connectivity, the study seeks to establish a more objective diagnostic approach for PTSD. This research is crucial for improving the accuracy of PTSD diagnoses and understanding its biological underpinnings.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 20-60 with a history of combat service and at least one life-threatening combat experience.

Not a fit: Patients with current psychiatric disorders other than PTSD or those unable to comply with study protocols may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and objective diagnoses of PTSD, improving treatment outcomes for affected individuals.

How similar studies have performed: While there have been studies exploring biological markers for PTSD, this approach aims to combine multiple biomarkers, making it a novel contribution to the field.

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.

Where this trial is running

Ramla

• Assaf-Harofeh Medical Center — Ramla, Israel (RECRUITING)

Study contacts

• Principal investigator: keren doenyas-barak, md — sagol center for hyperbaric medicine
• Study coordinator: keren doenyas-barak, MD

Conditions: Post Traumatic Stress Disorder