Neuroinflammation, Serotonin, Impulsivity and Suicide

Major Depressive Episode Clinical Trial

— NISIS  

Official title:

Neuroinflammation, Serotonin, Impulsivity and Suicide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02824081
• Other study ID #: UF9467
• Secondary ID: 2014-A01313-44
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2016
• Last updated: June 30, 2016
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: June 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: November 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depressive Episode
• Suicidal Behavior

Intervention

Biological:
• Blood sample
Blood sample in order to study inflammatory biomarkers and genetics purpose

Locations

Country	Name	City	State
France	University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of interleukin 2 (Il2) in a blood sample	Comparison of Il2 levels between patients with and without suicidal behaviour	inclusion visit	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No