Inflammation and Blood Brain Barrier Integrity as Biomarkers of Suicidal Behavior

NCT06047613 | Unknown

• 1 other identifier: RECHMPL22_0103
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 the blood brain barrier, which normally acts as a filter to ensure proper neuronal functioning, in suicidal patients. They propose to investigate peripheral inflammation, neurovascular permeability and miRNAs in suicidal behavior pathophysiology as biomarkers of suicidal behavior in depression

Conditions

Suicide; Depression

Keywords

suicide; depression

Outcome Measures

Primary Outcomes (2)

• Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.

  At inclusion

• Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.

  At 1 month follow-up

Secondary Outcomes (42)

• Cytokines' concentration by multiplex ELISA (pg/ml)

  At inclusion

• Cytokines' concentration by multiplex ELISA (pg/ml)

  At 1 month follow-up

• Specific proteins measurement (pg/ml)

  At inclusion

• Specific proteins measurement (pg/ml)

  At 1 month follow-up

• FACS analysis on fresh blood

  At inclusion

Study Arms (3)

Suicide attempters

EXPERIMENTAL

Currently depressed patients with a suicide attempt within the 8 last days (with a maximal lifetime number of 3 previous suicide attempt including the most recent );

Biological: Blood samples; Other: Hetero-questionnaires and auto-questionnaires; Other: Magnetic Resonance Imaging (MRI)

Affective controls

ACTIVE COMPARATOR

Currently depressed patients without any lifetime history of suicide attempt

Biological: Blood samples; Other: Hetero-questionnaires and auto-questionnaires; Other: Magnetic Resonance Imaging (MRI)

Healthy controls

ACTIVE COMPARATOR

Participants with no lifetime history of psychiatric disorders

Biological: Blood samples; Other: Hetero-questionnaires and auto-questionnaires; Other: Magnetic Resonance Imaging (MRI)

Interventions

Blood samples BIOLOGICAL

Blood samples will be collected at both visit between 8:30 a.m. and 10 a.m. and fasting from midnight.

Affective controls; Healthy controls; Suicide attempters

Hetero-questionnaires and auto-questionnaires OTHER

Questionnaires will be administrated at both visits to assess the suicide spectrum, the depression level and some personality traits. Heteroquestionnaires will be administrated during a clinical interview (1h) conducted by a psychiatrist or psychologist. Autoquestionnaires (45 min) will be completed by the participant himself.

Affective controls; Healthy controls; Suicide attempters

Magnetic Resonance Imaging (MRI) OTHER

MRI will be processed (at both visits for patients and at inclusion visit for healthy controls) to study between groups white matter microstructure and brain functional connectivity networks

Affective controls; Healthy controls; Suicide attempters

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 55 years old,
• Affiliated to a French National Social Security System
• Able to understand the nature, purpose and methodology of the study
• Able to give written informed consent
• Suicide attempters:
• Subject with a history of maximum 2 previous lifetime proven SA
• Affective controls:
• Subject without any lifetime history suicidal behavior (proven, interrupted or aborted)
• Healthy controls:
• \- Subject who have no current or past personal history of psychiatric disorders according to DSM5 criteria.
• History of psychotic disorders
• Diagnostic of illicit substance / alcohol use disorder within the last 6 months
• Current inflammation-related symptoms including fever and infectious or inflammatory disease
• Severe symptomatic or unstable medical condition (e.g., unstable endocrine or cardiovascular disease)
• Medical disorders affecting CNS function (e.g., history of severe head trauma, epilepsy, tumor)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Suicide; Depression

Interventions

Blood Specimen Collection; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Central Study Contacts

Philippe COURTET, MD PhD

CONTACT

+33 4 67 33 85 81; p-courtet@chu-montpellier.fr

Emilie OLIE, MD PhD

CONTACT

+33 4 67 33 85 81; e-olie@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: September 21, 2023
• Study Start: October 5, 2023
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

FR (1)