NCT02824081

Brief Summary

Suicide is a major health problem that causes annually a million death worlwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition (personality, family history of SB…) and stressful conditions (early life adversity). Studies show that suicide ideations could favour inflammation and that depression is associated with an elevated inflammation. Recent evidences also suggest that inflammatory mediators play a critical role in SB. The aim of the study is to evaluate the inflammatory markers rate on depressed patients with or without personal history of SB. In the second part of the study, the relations between the rates of inflammatory markers and characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression of 5HT2B receptor will be investigated.

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
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

June 30, 2016

Last Update Submit

June 30, 2016

Conditions

Major Depressive EpisodeSuicidal Behavior

Keywords

PsychiatryDepressive disorderSuicideInflammation

Outcome Measures

Primary Outcomes (1)

  • Rate of interleukin 2 (Il2) in a blood sample

    Comparison of Il2 levels between patients with and without suicidal behaviour

    inclusion visit

Secondary Outcomes (10)

  • Rate of inflammation markers (Interleukin 1, 4, 6, 8, 10, Tumor necrosis factor alpha (TNF-a), Interferon gamma (IFNg), Vascular endothelial growth factor (VEGF), kynurenin and c-reactive protein (CRP) in a blood sample

    inclusion visit

  • Rate of inflammation markers and suicide attempt

    inclusion visit

  • Rate of inflammation markers and violent suicide attempt

    inclusion visit

  • Rate of inflammation markers and suicide ideations

    inclusion visit

  • Relation between markers of inflammation and suicidal behavior characteristics

    inclusion visit

  • +5 more secondary outcomes

Study Arms (1)

Depressive patients

OTHER

Blood samples (inflammatory biomarkers and genetic purpose) on depressive patients with or without story of suicidal behavior

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

Blood sample in order to study inflammatory biomarkers and genetics purpose

Depressive patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages of 18 and 65
  • Main diagnosis of major depressive episode (DSM-IV criteria)
  • Having signed the informed consent
  • Able to understand nature, aims, and methodology of the study
  • Depressed patients with suicide attempt history :
  • Depressed patients without suicide attempt history :
  • Had never realized suicide attempt in his lifetime

You may not qualify if:

  • Patients suffering from inflammatories pathology
  • Antibiotic or anti-inflammatory current treatment
  • Pregnancy
  • Patient on protective measures (guardianship or trusteeship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Depressive DisorderSuicideInflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersSelf-Injurious BehaviorBehavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 6, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2017

Study Completion

November 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)