Clinical trial NCT04137458: Exploration of the Relationship Between Inflammation and Integrity of the Blood-Brain Barrier in Suicidal Behaviour
Official title: Exploration of the the Relationship Between Inflammation and Integrity of the Blood-brain Barrier in Suicidal Behaviour
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Psychiatry
Blood Brain Barrie
Suicide attempt
Inflammation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood level of S100B
timeFrame: at inclusion
Secondary outcomes:
measure: Determination of leukocyte signature associated with suicidal behavior and depression
timeFrame: at inclusion
measure: Profile of peripheral inflammation of each group
timeFrame: at inclusion
measure: Identification of general peripheral inflammation
timeFrame: at inclusion
measure: Pro-inflammatory profile based on cytokins of each group
timeFrame: at inclusion
measure: Profile of salivary interleukins
timeFrame: at inclusion
measure: Serum levels of glial fibrillary actin protein (GFAP)
timeFrame: at inclusion
measure: Serum levels of specific neuronal enolase (NSE)
timeFrame: at inclusion
measure: Serum levels of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)
timeFrame: at inclusion
measure: Salivary levels of S100B protein
timeFrame: at inclusion
measure: Salivary levels of specific neuronal enolase (NSE)
timeFrame: at inclusion
measure: Salivary levels of GFAP
timeFrame: at inclusion
measure: In vitro fluorescence ratio Dapi / phalloidin
timeFrame: at inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Philippe Courtet, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: