Skip to content

Exploration of the Relationship Between Inflammation and Integrity of the Blood-Brain Barrier in Suicidal Behaviour

Exploration of the the Relationship Between Inflammation and Integrity of the Blood-brain Barrier in Suicidal Behaviour

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04137458
Acronym
IBIS
Enrollment
105
Registered
2019-10-24
Start date
2019-11-07
Completion date
2022-07-31
Last updated
2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Psychiatry, Blood Brain Barrie, Suicide attempt, Inflammation

Brief 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 BBB which normally acts as a filter to ensure proper neuronal functioning in suicidal vs. non suicidal patients.

Detailed description

105 participants will be recruited : * 35 depressed patients having attempted suicide (maximum 3 attempts in life) * 35 depressed patients without history of suicide attempt (affective controls) * 35 healhy controls with no lifetime psychiatric history. Only one visit is planned. A clinical assessment (2 hours) will be performed to characterise pschopathology and suicidal characteristics. Blood and salivary samples will be obtained in order to measure inflammatory markers.

Interventions

Blood and salivary samples will be taken at inclusion and a psychiatric assessment will be carried out

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-55 years old * Able to understand nature, aims, and methodology of the study Depending on the population : * Current depressive episode (according to DSM-5 criteria) with a recent suicide attempt (within the 8 days before inclusion) and no more than 3 attempts in life * Current depressive episode (according to DSM-5 criteria) without suicide attempt * No psychiatric history (according to DSM-5 criteria)

Exclusion criteria

* Inflammatory diseases or intercurrent infections, or chronic diseases such as hepatitis C or B, HIV, Alzheimer's, cancer or autoimmune disease * Current antibiotic or anti-inflammatory treatments * Refusal to participate * Lifetime Schizoaffective disorder or schizophrenia * On protective measures (guardianship or trusteeship) * Deprived of liberty subject (administrative decision) * In exclusion period for another protocol * Not affiliated to a social security agency * Unable to understand and/or answer a questionnaire * Pregnant or lactating women

Design outcomes

Primary

MeasureTime frameDescription
Blood level of S100Bat inclusionBlood level of S100B measured in 3 groups (i.e. suicide attempters, affective controls, healthy controls)

Secondary

MeasureTime frameDescription
Profile of peripheral inflammation of each groupat inclusionCharacterization of activation state of leukocytes of CD4 / CD8 (T cells), NK cells, CD14 / CD33 (monocytes / macrophages)
Identification of general peripheral inflammationat inclusionBetween groups comparison of blood levels of CRP
Pro-inflammatory profile based on cytokins of each groupat inclusionSerum pro-inflammatory interleukins (IL) -1b, IL2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-9, IL-10, IL-12, IL-13 , TGF-b, interferon IFN-g, TNF-a, TNF-b
Profile of salivary interleukinsat inclusionProfile of salivary interleukins Il-6, Il-13 et Il-17 within and between groups
Serum levels of glial fibrillary actin protein (GFAP)at inclusionBetween group comparison of serum levels (ng / ml) of glial fibrillary actin protein (GFAP)
Determination of leukocyte signature associated with suicidal behavior and depressionat inclusionComparison of the number and percentage of leukocytes (lymphocytes, monocytes, neutrophils) in the blood between the 3 patients groups
Serum levels of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)at inclusionBetween group comparison of serum levels (ng / ml) of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)
Salivary levels of S100B proteinat inclusionBetween group comparison of salivary levels of S100B protein
Salivary levels of specific neuronal enolase (NSE)at inclusionBetween group comparison of salivary levels of specific neuronal enolase (NSE) in the 3 groups
Salivary levels of GFAPat inclusionBetween group comparison of salivary levels of GFAP in the 3 groups
In vitro fluorescence ratio Dapi / phalloidinat inclusionThe fluorescence ratio Dapi / phalloidin in a culture of neurovascular cells in the presence of the serum of the subjects (in vitro) in the 3 groups
Serum levels of specific neuronal enolase (NSE)at inclusionBetween group comparison of serum levels (ng / ml) of specific neuronal enolase (NSE)

Countries

France

Contacts

Primary ContactPhilippe Courtet, MD PhD
p-courtet@chu-montpellier.fr+33 4 67 33 85 81
Backup ContactEmilie Olie, MD PhD
e-olie@chu-montpellier.fr+33 4 67 33 85 81

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026