Pain Perception in Suicidal Behavior Vulnerability (DOCS)
In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain where mental trouble has a major influence. It is classified as preventable mortality. According to interpersonal psychological theory of suicide, the repeated exposition to stressful and painful events (as physical abuse) would facilitate suicide attempt through the increased pain tolerance. The social pain (or psychical pain on the broader sense) and physical pain are closely linked.
The investigators hypothesize that the measure of painful perception will be significantly superior on suicidals attempters compared to non-attempters. It will be the case for recent suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait. Moreover, the investigators expect that social distress induced by a social exclusion paradigm will be significantly superior on suicide attempters compared to non-attempters.
The aim of the study is to investigate the physical and psychic pain on depressed subjects with or without history of suicide attempts.
After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal dimension), subjects will be submitted to a painful thermic stimulation and will participate at a computer test of social exclusion (named Cyberball).
調査の概要
状態
条件
詳細な説明
242 depressed patients ( 81 recent suicide attempters, 81 former suicide attempters, 80 non-attempters)
First visit : clinical assessment Second visit : pain evaluation and blood sample (from one day to a week maximum after the first visit).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Montpellier、フランス、34295
- Montpellier Hospital University
-
-
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:
- aged by 18 years old
- came from West Europe, excepted Basque and Sardinian (because of genetics analysis)
- main diagnosis of major depressive episode (DSM V criteria)
- not having take antalgics in the 24 hours before assessment
- received a minimal psychotrope treatment (clinician evaluation)
- Able to understand nature, aims, methodology of the study
- Agree to cooperate in clinical and biological assessment
- Having signed informed consent
Specific inclusion criteria :
81 recent suicide attempters (being hospitalised for suicidal attempts and having realised a suicide attempts 8 days before inclusion) 81 former suicide attempters (having realised in his lifetime a suicide attempt, one month before inclusion)
Exclusion criteria:
- Current diagnosis of manic, hypomanic or alcohol dependance or substance abuse in the last 6 months, or diagnosis of schizophrenia or schizoaffective disorder in his lifetime
- Current algic and chronic neurologic disease
- Current or actual treatment by tricyclic antidepressant and Serotonin and norepinephrine reuptake inhibitors(SNRIs)
- Pregnancy
- Patients on protective measure
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
- 主な目的：他の
- 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：Study participant
All the participants performed blood sample for genetic purpose, psychiatric assessment and pain investigation:
|
All the participant will performed the same evaluation and blood analysis:
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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 |
|---|---|---|
|
Pain tolerance reported by the patient
時間枠：During thermal stimulation
|
temperature measured when the subject will perceive as intolerable the pain following a painful stimulation performed using a thermode
|
During thermal stimulation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain intensity reported by the patient
時間枠：During thermal stimulation
|
comparison between the three groups of the pain intensity (assessed by likert scale) at constant temperature (43 ° C)
|
During thermal stimulation
|
|
Pain threshold reported by the patient
時間枠：During thermal stimulation
|
comparison between the three groups of the pain threshold (temperature perceived as painful)
|
During thermal stimulation
|
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Temperature assessed at 4/10 on likert scale
時間枠：During thermal stimulation performed at the inclusion
|
comparison between the three groups of the temperature assessed at 4/10 on a visual analogic painful scale, kinetics of pain intensity by visual analog scale (VAS) scale.
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During thermal stimulation performed at the inclusion
|
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Kinetics of pain intensity
時間枠：During thermal stimulation performed at the inclusion
|
comparison between the three groups of kinetics of pain intensity by visual analog scale (VAS) scale.
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During thermal stimulation performed at the inclusion
|
|
Social distress perception assessed by social distress questionnaire
時間枠：At V2 (one week maximum after the inclusion)
|
comparison between the three groups of the score of social distress scale after cyberball game
|
At V2 (one week maximum after the inclusion)
|
|
Social distress perception assessed by the Rejection Sensitivity Questionnaire (RSQ)
時間枠：At the inclusion
|
comparison between the three groups of the score of social distress scale after cyberball game
|
At the inclusion
|
|
Social rejection sensitivity assessed by the Rejection Sensitivity Questionnaire (RSQ)
時間枠：At the inclusion
|
comparison between the three groups of the score of social rejection sensitivity by RSQ
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At the inclusion
|
|
Psychological pain intensity
時間枠：At V2 (one week maximum after the inclusion)
|
comparison between the three groups of the score of psychological pain intensity assessed by VAS scale.
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At V2 (one week maximum after the inclusion)
|
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Measure of cardiac frequency in response to thermal pain
時間枠：At V2 (one week maximum after the inclusion)
|
comparison between the three groups of the cardiac frequency.
|
At V2 (one week maximum after the inclusion)
|
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 (実際)
研究の完了 (実際)
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 (実際)
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
本研究に関する用語
その他の研究ID番号
- UF 9185
- 2013-A01029-36 (その他の識別子：Agence Nationale de Sécurité des Médicaments)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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