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

Depression Clinical Trial

— IBIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137458
• Other study ID #: RECHMPL19_0227
• Secondary ID: 2019-A01277-50
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2019
• Est. completion date: July 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: Philippe Courtet, MD PhD
• Phone: +33 4 67 33 85 81
• Email: p-courtet[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Inflammation

Intervention

Biological:
• Biological analysis
Blood and salivary samples will be taken at inclusion and a psychiatric assessment will be carried out

Locations

Country	Name	City	State
France	University hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood level of S100B	Blood level of S100B measured in 3 groups (i.e. suicide attempters, affective controls, healthy controls)	at inclusion
Secondary	Determination of leukocyte signature associated with suicidal behavior and depression	Comparison of the number and percentage of leukocytes (lymphocytes, monocytes, neutrophils) in the blood between the 3 patients groups	at inclusion
Secondary	Profile of peripheral inflammation of each group	Characterization of activation state of leukocytes of CD4 / CD8 (T cells), NK cells, CD14 / CD33 (monocytes / macrophages)	at inclusion
Secondary	Identification of general peripheral inflammation	Between groups comparison of blood levels of CRP	at inclusion
Secondary	Pro-inflammatory profile based on cytokins of each group	Serum 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	at inclusion
Secondary	Profile of salivary interleukins	Profile of salivary interleukins Il-6, Il-13 et Il-17 within and between groups	at inclusion
Secondary	Serum levels of glial fibrillary actin protein (GFAP)	Between group comparison of serum levels (ng / ml) of glial fibrillary actin protein (GFAP)	at inclusion
Secondary	Serum levels of specific neuronal enolase (NSE)	Between group comparison of serum levels (ng / ml) of specific neuronal enolase (NSE)	at inclusion
Secondary	Serum levels of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)	Between group comparison of serum levels (ng / ml) of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)	at inclusion
Secondary	Salivary levels of S100B protein	Between group comparison of salivary levels of S100B protein	at inclusion
Secondary	Salivary levels of specific neuronal enolase (NSE)	Between group comparison of salivary levels of specific neuronal enolase (NSE) in the 3 groups	at inclusion
Secondary	Salivary levels of GFAP	Between group comparison of salivary levels of GFAP in the 3 groups	at inclusion
Secondary	In vitro fluorescence ratio Dapi / phalloidin	The 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	at inclusion