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

NCT ID: NCT04137458

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-07

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Participants

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

Group Type EXPERIMENTAL

Biological analysis

Intervention Type BIOLOGICAL

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

Interventions

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Biological analysis

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Courtet, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University hospital

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe Courtet, MD PhD

Role: CONTACT

[email protected]
+33 4 67 33 85 81

Emilie Olie, MD PhD

Role: CONTACT

[email protected]
+33 4 67 33 85 81

Facility Contacts

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Catherine Genty, MD

Role: primary

[email protected]
+33 4 67 99 61 45 75

Other Identifiers

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2019-A01277-50

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL19_0227

Identifier Type: -

Identifier Source: org_study_id