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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Montpellier, Frankrike, 34295
- Rekruttering
- University Hospital
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Ta kontakt med:
- Catherine GENTY, MD
- Telefonnummer: +33 4 67 99 61 45 75
- E-post: c-genty@chu-montpellier.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of interleukin 2 (Il2) in a blood sample
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UF9467
- 2014-A01313-44 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
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