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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Montpellier, Ranska, 34295
- Rekrytointi
- University Hospital
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Ottaa yhteyttä:
- Catherine GENTY, MD
- Puhelinnumero: +33 4 67 99 61 45 75
- Sähköposti: c-genty@chu-montpellier.fr
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Muut: Depressive patients
Blood samples (inflammatory biomarkers and genetic purpose) on depressive patients with or without story of suicidal behavior
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Blood sample in order to study inflammatory biomarkers and genetics purpose
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Rate of interleukin 2 (Il2) in a blood sample
Aikaikkuna: inclusion visit
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Comparison of Il2 levels between patients with and without suicidal behaviour
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inclusion visit
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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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
Aikaikkuna: inclusion visit
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Comparison of the levels of theses markers between patients with and without suicidal behaviour
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inclusion visit
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Rate of inflammation markers and suicide attempt
Aikaikkuna: inclusion visit
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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
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inclusion visit
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Rate of inflammation markers and violent suicide attempt
Aikaikkuna: inclusion visit
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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
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inclusion visit
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Rate of inflammation markers and suicide ideations
Aikaikkuna: inclusion visit
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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
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inclusion visit
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Relation between markers of inflammation and suicidal behavior characteristics
Aikaikkuna: inclusion visit
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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)
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inclusion visit
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Relation between markers of inflammation and impulsivity
Aikaikkuna: inclusion visit
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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)
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inclusion visit
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Relation between markers of inflammation and psychological pain
Aikaikkuna: inclusion visit
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Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and psychological pain (by Likert scale)
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inclusion visit
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Relation between markers of inflammation and child abuse
Aikaikkuna: inclusion visit
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Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and child abuse
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inclusion visit
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Relation between markers of inflammation and gene expression
Aikaikkuna: inclusion visit
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Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and gene expression of 5HT2B receptor
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inclusion visit
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Markers of inflammation as a risk factor for suicidal behavior
Aikaikkuna: at 6 months
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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.
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at 6 months
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- UF9467
- 2014-A01313-44 (Muu tunniste: ANSM)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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