Neuroinflammation, Serotonin, Impulsivity and Suicide

NCT ID: NCT02824081

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Major Depressive Episode; Suicidal Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Depressive patients

Blood samples (inflammatory biomarkers and genetic purpose) on depressive patients with or without story of suicidal behavior

Group Type: OTHER

Blood sample

Intervention Type: BIOLOGICAL

Blood sample in order to study inflammatory biomarkers and genetics purpose

Interventions

Blood sample

Blood sample in order to study inflammatory biomarkers and genetics purpose

Intervention Type: BIOLOGICAL

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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Catherine GENTY, MD

Role: primary

c-genty@chu-montpellier.fr

+33 4 67 99 61 45 75

Other Identifiers

2014-A01313-44

Identifier Type: OTHER

Identifier Source: secondary_id

UF9467

Identifier Type: -

Identifier Source: org_study_id