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Neuroinflammation, Serotonin, Impulsivity and Suicide

Neuroinflammation, Serotonin, Impulsivity and Suicide

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02824081
Acronym
NISIS
Enrollment
280
Registered
2016-07-06
Start date
2015-11-30
Completion date
2017-11-30
Last updated
2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Episode, Suicidal Behavior

Keywords

Psychiatry, Depressive disorder, Suicide, Inflammation

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.

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.

Interventions

BIOLOGICALBlood sample

Blood sample in order to study inflammatory biomarkers and genetics purpose

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Rate of interleukin 2 (Il2) in a blood sampleinclusion visitComparison of Il2 levels between patients with and without suicidal behaviour

Secondary

MeasureTime frameDescription
Rate of inflammation markers and suicide attemptinclusion visitComparison 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
Rate of inflammation markers and violent suicide attemptinclusion visitComparison 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
Rate of inflammation markers and suicide ideationsinclusion visitComparison of rate bloddmarkers (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with and without current suicide ideation
Relation between markers of inflammation and suicidal behavior characteristicsinclusion visitStudying 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)
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 sampleinclusion visitComparison of the levels of theses markers between patients with and without suicidal behaviour
Relation between markers of inflammation and psychological paininclusion visitStudying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and psychological pain (by Likert scale)
Relation between markers of inflammation and child abuseinclusion visitStudying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and child abuse
Relation between markers of inflammation and gene expressioninclusion visitStudying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and gene expression of 5HT2B receptor
Markers of inflammation as a risk factor for suicidal behaviorat 6 monthsStudying 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.
Relation between markers of inflammation and impulsivityinclusion visitStudying 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026