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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological analysis
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Psychiatry, Blood Brain Barrie, Suicide attempt, Inflammation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

The investigator will withdraw biological samples and a biological and DNA bank will also be realized

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Profile of peripheral inflammation of each group
Characterization of activation state of leukocytes of CD4 / CD8 (T cells), NK cells, CD14 / CD33 (monocytes / macrophages)
Identification of general peripheral inflammation
Between groups comparison of blood levels of CRP
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
Profile of salivary interleukins
Profile of salivary interleukins Il-6, Il-13 et Il-17 within and between groups
Serum levels of glial fibrillary actin protein (GFAP)
Between group comparison of serum levels (ng / ml) of glial fibrillary actin protein (GFAP)
Serum levels of specific neuronal enolase (NSE)
Between group comparison of serum levels (ng / ml) of specific neuronal enolase (NSE)
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)
Salivary levels of S100B protein
Between group comparison of salivary levels of S100B protein
Salivary levels of specific neuronal enolase (NSE)
Between group comparison of salivary levels of specific neuronal enolase (NSE) in the 3 groups
Salivary levels of GFAP
Between group comparison of salivary levels of GFAP in the 3 groups
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

Full Information

First Posted
October 21, 2019
Last Updated
October 22, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04137458
Brief Title
Exploration of the Relationship Between Inflammation and Integrity of the Blood-Brain Barrier in Suicidal Behaviour
Acronym
IBIS
Official Title
Exploration of the the Relationship Between Inflammation and Integrity of the Blood-brain Barrier in Suicidal Behaviour
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Psychiatry, Blood Brain Barrie, Suicide attempt, Inflammation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
The investigator will withdraw biological samples and a biological and DNA bank will also be realized
Intervention Type
Biological
Intervention Name(s)
Biological analysis
Intervention Description
Blood and salivary samples will be taken at inclusion and a psychiatric assessment will be carried out
Primary Outcome Measure Information:
Title
Blood level of S100B
Description
Blood level of S100B measured in 3 groups (i.e. suicide attempters, affective controls, healthy controls)
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Determination of leukocyte signature associated with suicidal behavior and depression
Description
Comparison of the number and percentage of leukocytes (lymphocytes, monocytes, neutrophils) in the blood between the 3 patients groups
Time Frame
at inclusion
Title
Profile of peripheral inflammation of each group
Description
Characterization of activation state of leukocytes of CD4 / CD8 (T cells), NK cells, CD14 / CD33 (monocytes / macrophages)
Time Frame
at inclusion
Title
Identification of general peripheral inflammation
Description
Between groups comparison of blood levels of CRP
Time Frame
at inclusion
Title
Pro-inflammatory profile based on cytokins of each group
Description
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
Time Frame
at inclusion
Title
Profile of salivary interleukins
Description
Profile of salivary interleukins Il-6, Il-13 et Il-17 within and between groups
Time Frame
at inclusion
Title
Serum levels of glial fibrillary actin protein (GFAP)
Description
Between group comparison of serum levels (ng / ml) of glial fibrillary actin protein (GFAP)
Time Frame
at inclusion
Title
Serum levels of specific neuronal enolase (NSE)
Description
Between group comparison of serum levels (ng / ml) of specific neuronal enolase (NSE)
Time Frame
at inclusion
Title
Serum levels of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)
Description
Between group comparison of serum levels (ng / ml) of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)
Time Frame
at inclusion
Title
Salivary levels of S100B protein
Description
Between group comparison of salivary levels of S100B protein
Time Frame
at inclusion
Title
Salivary levels of specific neuronal enolase (NSE)
Description
Between group comparison of salivary levels of specific neuronal enolase (NSE) in the 3 groups
Time Frame
at inclusion
Title
Salivary levels of GFAP
Description
Between group comparison of salivary levels of GFAP in the 3 groups
Time Frame
at inclusion
Title
In vitro fluorescence ratio Dapi / phalloidin
Description
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
Time Frame
at inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Courtet, MD PhD
Phone
+33 4 67 33 85 81
Email
p-courtet@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie Olie, MD PhD
Phone
+33 4 67 33 85 81
Email
e-olie@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Courtet, MD PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Genty, MD
Phone
+33 4 67 99 61 45 75
Email
c-genty@chu-montpellier.fr

12. IPD Sharing Statement

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

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