Neuroinflammation, Serotonin, Impulsivity and Suicide

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neuroinflammation, Serotonin, Impulsivity and Suicide

Conditions
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Major Depressive Episode, Suicidal Behavior

Intervention / Treatment
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* Biological: Blood sample


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatry, Depressive disorder, Suicide, Inflammation