Clinical trial NCT02824081: Neuroinflammation, Serotonin, Impulsivity and Suicide
Official title: Neuroinflammation, Serotonin, Impulsivity and Suicide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Episode
Suicidal Behavior
Keywords: Psychiatry
Depressive disorder
Suicide
Inflammation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of interleukin 2 (Il2) in a blood sample
timeFrame: inclusion visit
Secondary outcomes:
measure: 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
timeFrame: inclusion visit
measure: Rate of inflammation markers and suicide attempt
timeFrame: inclusion visit
measure: Rate of inflammation markers and violent suicide attempt
timeFrame: inclusion visit
measure: Rate of inflammation markers and suicide ideations
timeFrame: inclusion visit
measure: Relation between markers of inflammation and suicidal behavior characteristics
timeFrame: inclusion visit
measure: Relation between markers of inflammation and impulsivity
timeFrame: inclusion visit
measure: Relation between markers of inflammation and psychological pain
timeFrame: inclusion visit
measure: Relation between markers of inflammation and child abuse
timeFrame: inclusion visit
measure: Relation between markers of inflammation and gene expression
timeFrame: inclusion visit
measure: Markers of inflammation as a risk factor for suicidal behavior
timeFrame: at 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
Study officials:
References: