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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Blood samples | Blood samples will be collected at both visit between 8:30 a.m. and 10 a.m. and fasting from midnight. |
| OTHER | 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. |
| OTHER | 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 |
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.