Clinical trial

Inflammation and Blood Brain Barrier Integrity as Biomarkers of Suicidal Behavior

Name
RECHMPL22_0103
Description
Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in microglial activation in the brain tissue of suicide victims. However the relationship between peripheral and central inflammation in suicide is probably mediated by complex biological processes that are yet elucidated. An increase of blood S100B levels (biomarker of neurovascular damage; PMID 14530574) has been reported in adolescents with suicidal ideation vs. controls and independently of psychiatric disorder. The investigators hypothesize that peripheral inflammation may alter the blood brain barrier, which normally acts as a filter to ensure proper neuronal functioning, in suicidal patients. They propose to investigate peripheral inflammation, neurovascular permeability and miRNAs in suicidal behavior pathophysiology as biomarkers of suicidal behavior in depression
Trial arms
Trial start
2023-10-05
Estimated PCD
2025-05-01
Trial end
2025-10-01
Status
Recruiting
Treatment
Blood samples
Blood samples will be collected at both visit between 8:30 a.m. and 10 a.m. and fasting from midnight.
Arms:
Affective controls, Healthy controls, Suicide attempters
Hetero-questionnaires and auto-questionnaires
Questionnaires will be administrated at both visits to assess the suicide spectrum, the depression level and some personality traits. Heteroquestionnaires will be administrated during a clinical interview (1h) conducted by a psychiatrist or psychologist. Autoquestionnaires (45 min) will be completed by the participant himself.
Arms:
Affective controls, Healthy controls, Suicide attempters
Magnetic Resonance Imaging (MRI)
MRI will be processed (at both visits for patients and at inclusion visit for healthy controls) to study between groups white matter microstructure and brain functional connectivity networks
Arms:
Affective controls, Healthy controls, Suicide attempters
Size
150
Primary endpoint
Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.
At inclusion
Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.
At 1 month follow-up
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-11-29

1 organization

1 product

2 indications

Indication
Suicide