NCT04137458

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

November 7, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

2.6 years

First QC Date

October 21, 2019

Last Update Submit

October 22, 2021

Conditions

Depression

Keywords

PsychiatryBlood Brain BarrieSuicide attemptInflammation

Outcome Measures

Primary Outcomes (1)

  • Blood level of S100B

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

    at inclusion

Secondary Outcomes (12)

  • Determination of leukocyte signature associated with suicidal behavior and depression

    at inclusion

  • Profile of peripheral inflammation of each group

    at inclusion

  • Identification of general peripheral inflammation

    at inclusion

  • Pro-inflammatory profile based on cytokins of each group

    at inclusion

  • Profile of salivary interleukins

    at inclusion

  • +7 more secondary outcomes

Study Arms (1)

Participants

EXPERIMENTAL

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

Biological: Biological analysis

Interventions

Biological analysisBIOLOGICAL

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

Participants

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Able to understand nature, aims, and methodology of the study
  • Depending on the population :
  • Current depressive episode (according to DSM-5 criteria) without suicide attempt
  • No psychiatric history (according to DSM-5 criteria)

You may not qualify if:

  • 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)
  • Not affiliated to a social security agency
  • Unable to understand and/or answer a questionnaire
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

DepressionSuicide, AttemptedInflammation

Interventions

Biological Oxygen Demand Analysis

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideSelf-Injurious BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environmental MonitoringEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Philippe Courtet, MD PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Courtet, MD PhD

CONTACT

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

Emilie Olie, MD PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 24, 2019

Study Start

November 7, 2019

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

October 25, 2021

Record last verified: 2021-10

Locations

FR(1)