Clinical Trials Directory

Trials / Unknown

UnknownNCT06047613

Inflammation and Blood Brain Barrier Integrity as Biomarkers of Suicidal Behavior

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

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

Detailed description

150 participants will be enrolled, divided into 3 groups: * 50 Suicide attempters, i.e. currently depressed patients with a suicide attempt within the 8 last days (with a maximal lifetime number of 3 previous suicide attempts, including the most recent); * 50 Affective controls, i.e. currently depressed patients without any lifetime history of suicide attempt; * 50 Healthy controls (age- and gender-matched to patients' groups) with no lifetime history of psychiatric disorders. The protocol includes two visits for patients (suicide attempters and affective controls) and only one visit (inclusion) for healthy controls. The first visit is the inclusion visit (Day 0-Day 8). Day 0 is the date of the last suicide attempt for the suicide attempters group and the date of signature of the consent for the affective control and healthy control groups. All the visit exams will be performed within 8 days after Day 0. The second visit takes place one month +/- one week after inclusion. At each visit, a clinical assessment will be performed to characterise psychopathology and suicidal characteristics. Blood samples will be obtained in order to measure inflammatory markers. An MRI will be performed on order to study white matter microstructure and brain functional connectivity networks.

Conditions

Interventions

TypeNameDescription
BIOLOGICALBlood samplesBlood samples will be collected at both visit between 8:30 a.m. and 10 a.m. and fasting from midnight.
OTHERHetero-questionnaires and auto-questionnairesQuestionnaires 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.
OTHERMagnetic 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

Timeline

Start date
2023-10-05
Primary completion
2025-05-01
Completion
2025-10-01
First posted
2023-09-21
Last updated
2023-11-29

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06047613. Inclusion in this directory is not an endorsement.