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Neuroinflammation, Serotonin, Impulsivity and Suicide (NISIS)

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ClinicalTrials.gov Identifier: NCT02824081
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Major Depressive Episode Suicidal Behavior Biological: Blood sample Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Neuroinflammation, Serotonin, Impulsivity and Suicide
Study Start Date : November 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Serotonin

Arm Intervention/treatment
Depressive patients
Blood samples (inflammatory biomarkers and genetic purpose) on depressive patients with or without story of suicidal behavior
Biological: Blood sample
Blood sample in order to study inflammatory biomarkers and genetics purpose




Primary Outcome Measures :
  1. Rate of interleukin 2 (Il2) in a blood sample [ Time Frame: inclusion visit ]
    Comparison of Il2 levels between patients with and without suicidal behaviour


Secondary Outcome Measures :
  1. 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 [ Time Frame: inclusion visit ]
    Comparison of the levels of theses markers between patients with and without suicidal behaviour

  2. Rate of inflammation markers and suicide attempt [ Time Frame: inclusion visit ]
    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

  3. Rate of inflammation markers and violent suicide attempt [ Time Frame: inclusion visit ]
    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

  4. Rate of inflammation markers and suicide ideations [ Time Frame: inclusion visit ]
    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

  5. Relation between markers of inflammation and suicidal behavior characteristics [ Time Frame: inclusion visit ]
    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)

  6. Relation between markers of inflammation and impulsivity [ Time Frame: inclusion visit ]
    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)

  7. Relation between markers of inflammation and psychological pain [ Time Frame: inclusion visit ]
    Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and psychological pain (by Likert scale)

  8. Relation between markers of inflammation and child abuse [ Time Frame: inclusion visit ]
    Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and child abuse

  9. Relation between markers of inflammation and gene expression [ Time Frame: inclusion visit ]
    Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and gene expression of 5HT2B receptor

  10. Markers of inflammation as a risk factor for suicidal behavior [ Time Frame: at 6 months ]
    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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824081


Locations
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France
University Hospital Recruiting
Montpellier, France, 34295
Contact: Catherine GENTY, MD    +33 4 67 99 61 45 75    c-genty@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02824081    
Other Study ID Numbers: UF9467
2014-A01313-44 ( Other Identifier: ANSM )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Montpellier:
Psychiatry
Depressive disorder
Suicide
Inflammation
Additional relevant MeSH terms:
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Suicide
Impulsive Behavior
Self-Injurious Behavior
Behavioral Symptoms