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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Montpellier、フランス、34295
- 募集
- University Hospital
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コンタクト：
- Catherine GENTY, MD
- 電話番号：+33 4 67 99 61 45 75
- メール：c-genty@chu-montpellier.fr
-
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Depressive patients
Blood samples (inflammatory biomarkers and genetic purpose) on depressive patients with or without story of suicidal behavior
|
Blood sample in order to study inflammatory biomarkers and genetics purpose
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of interleukin 2 (Il2) in a blood sample
時間枠：inclusion visit
|
Comparison of Il2 levels between patients with and without suicidal behaviour
|
inclusion visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：inclusion visit
|
Comparison of the levels of theses markers between patients with and without suicidal behaviour
|
inclusion visit
|
|
Rate of inflammation markers and suicide attempt
時間枠：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
|
inclusion visit
|
|
Rate of inflammation markers and violent suicide attempt
時間枠：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
|
inclusion visit
|
|
Rate of inflammation markers and suicide ideations
時間枠：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
|
inclusion visit
|
|
Relation between markers of inflammation and suicidal behavior characteristics
時間枠：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)
|
inclusion visit
|
|
Relation between markers of inflammation and impulsivity
時間枠：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)
|
inclusion visit
|
|
Relation between markers of inflammation and psychological pain
時間枠：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)
|
inclusion visit
|
|
Relation between markers of inflammation and child abuse
時間枠：inclusion visit
|
Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and child abuse
|
inclusion visit
|
|
Relation between markers of inflammation and gene expression
時間枠：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
|
inclusion visit
|
|
Markers of inflammation as a risk factor for suicidal behavior
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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