Investigating inflammation and blood-brain barrier integrity in suicidal behavior
Inflammation and Blood Brain Barrier Integrity as Biomarkers of Suicidal Behavior
NA · University Hospital, Montpellier · NCT06047613
This study is trying to see if inflammation in the body and the health of the brain's protective barrier are linked to suicidal behavior in people with depression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06047613 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between peripheral inflammation and blood-brain barrier integrity in individuals exhibiting suicidal behavior, particularly in the context of depression. It will enroll 150 participants divided into three groups: suicide attempters, affective controls, and healthy controls. Participants will undergo clinical assessments, blood sample collection for inflammatory marker analysis, and MRI scans to evaluate brain structure and connectivity. The goal is to identify biomarkers that could help understand the pathophysiology of suicidal behavior.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 55 with a current major depressive episode, specifically those who have recently attempted suicide or have a history of depression without suicidal behavior.
Not a fit: Patients with no current or past psychiatric history or those outside the age range of 18 to 55 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of biomarkers that improve the understanding and treatment of suicidal behavior in depressed patients.
How similar studies have performed: While there is emerging evidence linking inflammation to suicidal behavior, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Common inclusion criteria: * Aged between 18 and 55 years old, * Affiliated to a French National Social Security System * Able to understand the nature, purpose and methodology of the study * Able to give written informed consent Specific inclusion criteria Suicide attempters: * Subject with a main psychiatric diagnosis of current major depressive episode according to DSM-5 criteria (the existence of psychiatric comorbidities is not a non-inclusion criterion) * Subject with a recent history of proven suicide attempt (within the 8 days before inclusion) * Subject with a history of maximum 2 previous lifetime proven SA Affective controls: * Subject with a main psychiatric diagnosis of current major depressive episode according to DSM-5 criteria (the existence of psychiatric comorbidities is not a non-inclusion criterion), * Subject without any lifetime history suicidal behavior (proven, interrupted or aborted) Healthy controls: - Subject who have no current or past personal history of psychiatric disorders according to DSM5 criteria. Non inclusion criteria * History of psychotic disorders * Diagnostic of illicit substance / alcohol use disorder within the last 6 months * Current inflammation-related symptoms including fever and infectious or inflammatory disease * Severe symptomatic or unstable medical condition (e.g., unstable endocrine or cardiovascular disease) * Medical disorders affecting CNS function (e.g., history of severe head trauma, epilepsy, tumor) * Current use of specific medications known to affect the immune system, such as corticosteroids, non-steroid anti-inflammatory drugs, aspirin and statins * Contraindication to MRI or impossibility to assess, or doubt about a contraindication to the MRI: metallic artificial heart valve, pacemaker, cerebrovascular clips ferromagnetic materials, metallic foreign body that can be mobilized, in particular cerebral or intraocular, prosthesis ferromagnetic, impossibility of absolute immobility in supine position, claustrophobia. * Vaccination in the last month * Law protected or deprived of liberty subject * Pregnant and breastfeeding women * BMI \> 30 kg/m2 * Having reached 6000€ annual compensation for participating to clinical trials * Being in exclusion period for another study
Where this trial is running
Montpellier
- University hospital — Montpellier, France (RECRUITING)
Study contacts
- Study coordinator: Philippe COURTET, MD PhD
- Email: p-courtet@chu-montpellier.fr
- Phone: +33 4 67 33 85 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Suicide, Depression, suicide, depression