Neuroinflammation, Serotonin, Impulsivity and Suicide (NISIS)

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.

Study Overview

• Status: Unknown
• Conditions: Suicidal Behavior; Major Depressive Episode
• Intervention / Treatment: Biological: Blood sample

Detailed Description

Over one year, we will recruit 280 patients suffering from a major depressive episode with (n=140) and without any history of suicide attempt (n=140), from a specialized clinic for mood disorders and SB.

First visit : clinical, biological and neuropsychological assessment

Second visit, at 6 month : Follow-up visit in the department or interview by telephone in order to assess suicidal ideations or suicide attempts since the inclusion.

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • University Hospital
    • Contact: Catherine GENTY, MD; Phone Number: +33 4 67 99 61 45 75; Email: c-genty@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Specifics Inclusion criteria:

• Depressed patients with suicide attempt history :

  • Have done in his lifetime at least one suicide attempt (however the period of time between inclusion and suicide attempt)

• Depressed patients without suicide attempt history :

  • Had never realized suicide attempt in his lifetime

Exclusion Criteria:

• Patients suffering from inflammatories pathology
• Antibiotic or anti-inflammatory current treatment
• Pregnancy
• Participation in another clinical trial with an exclusion period
• Patient on protective measures (guardianship or trusteeship)

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Depressive patients; Blood samples (inflammatory biomarkers and genetic purpose) on depressive patients with or without story of suicidal behavior	Biological: Blood sample; Blood sample in order to study inflammatory biomarkers and genetics purpose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of interleukin 2 (Il2) in a blood sample	Comparison of Il2 levels between patients with and without suicidal behaviour	inclusion visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Comparison of the levels of theses markers between patients with and without suicidal behaviour	inclusion visit
Rate of inflammation markers and suicide attempt	Comparison of rate bloodmarkers inflammation (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with latest suicide attempt and depressed patients with an history of suicide attempt	inclusion visit
Rate of inflammation markers and violent suicide attempt	Comparison of rate bloodmarkers inflammation (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with and without violent suicide attempt	inclusion visit
Rate of inflammation markers and suicide ideations	Comparison of rate bloddmarkers (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with and without current suicide ideation	inclusion visit
Relation between markers of inflammation and suicidal behavior characteristics	Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and suicidal behaviour characteristics (the last and the most serious) (intentionality, planification, lethality)	inclusion visit
Relation between markers of inflammation and impulsivity	Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and impulsivity (by Baratt Impulsivity Scale and neuropsychological tests)	inclusion visit
Relation between markers of inflammation and psychological pain	Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and psychological pain (by Likert scale)	inclusion visit
Relation between markers of inflammation and child abuse	Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and child abuse	inclusion visit
Relation between markers of inflammation and gene expression	Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and gene expression of 5HT2B receptor	inclusion visit
Markers of inflammation as a risk factor for suicidal behavior	Studying bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) as suicidal behaviour risk factor (suicide ideations and/or suicide attempt) with a 6 months follow-up.	at 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Inflammation; Psychiatry; Suicide; Depressive disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Impulsive Behavior
• Other Study ID Numbers: UF9467; 2014-A01313-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO