Electrodermal Hyporeactivity And Depression (EUDOR-A)
Naturalistic Clinical Studies in Several Centres of Electrodermal Hyporeactivity in Adult Patients With Primary Depression
調査の概要
詳細な説明
This EUDOR-A study is a naturalistic, european and multicentric study. In France, patient's recruitment will be only conducted by investigators within the Department of Psychiatric Emergencies and Post Acute Care, University Hospital of Montpellier.
Over one year, 233 patients suffering from a major depressive episode with (n=70) and without any history of suicide attempt (n=163) will be recruited.
The maximum period of participation for a given patient will be 12 months with 2 phone assessments at 6 month and 12 month.
Inclusion visit: clinical and biological assessment and Edor test. Second and third visits at 6 and 12 month: Follow up visits 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 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Montpellier、フランス、34295
- Montpellier University Hospital
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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:
All subjects men and women will necessarily meet the following inclusion criteria:
- In- and outpatients, with a diagnosis of primary depression according to the International classification of Disease (ICD-10) should be included as a routine. That is, patients in a primary unipolar major episode or dysthymia or primary depression with a personality disorder or an anxiety disorder as secondary diagnoses and primary bipolar disorder in a non-hypomanic and non-manic phase are expected to be included.
- Age : 18 years or older
- written informed consent
- must belong to social safety system
- To be able to understand instructions for the EDOR Test, the aim and the methodology of the study.
Exclusion criteria:
- diagnosed or suspected dementia
- Acute known or suspected alcohol or other substance abuse. The condition of past substance abuse (i.e. alcohol abuse or dependance, drug abuse or dependance ) should be noted in the comment field of the EDOR Test routine and patient must have been abstinent for at least one year.
- Serious problems of hearing, the patient should not participate.
- Refusal of participation
- Subject deprived of liberty (by judicial or administrative decision)
- Subject protected by law.
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:診断
- 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 |
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実験的:Depressive patients
EDOR test on depressed patients with or without personal history of suicidal behavior
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The ElectroDermal Orienting Reactivity (EDOR) specifically is optimized for the detection of electrodermal hyporeactivity. The EDOR investigation last about 30 min. The EDOR Test Data is sent immediately after each EDOR Test for each Test Person to a Company named EMOTRA for blind analyses. The EDOR Test Report may change the basis for the assessment and a new risk assessment may be needed to be done. Blood sample and clinical assessment |
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 |
---|---|---|
Specificity and sensibility of the electrodermal hyporeactivity
時間枠:At 6 and 12 month
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Correlation between the Edor Test results and suicidal behavior
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At 6 and 12 month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
時間枠:At 6 month
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Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal
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At 6 month
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The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
時間枠:At 6 and 12 month
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Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal
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At 6 and 12 month
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Electrodermal activity in depressive and suicidal patients with or without insomnia.
時間枠:At 6 and 12 month
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Comparison of test result between patients with insomnia and patient without insomnia.
Insomnia will be evaluated with the "Insomnia severity index" (ISI).
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At 6 and 12 month
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Genetic vulnerability to suicidal behavior by polymorphism analysis in blood sample
時間枠:At the inclusion
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To study the polymorphisms by blood sample analysis of the promotor of Spermidine/Spermine Acetyltransferase 1 (SAT1), Phenylethanolamine N-Methyltransferase (PNMT) and Noradrenalin Transporter (NAT).
between depressed patients with suicidal behavior and depressed patients without suicidal behavior.
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At the inclusion
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The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Risk Rescue Rating Scale (RRRS)
時間枠:At 6 and 12 month
|
Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal
|
At 6 and 12 month
|
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Beck Scale for Suicidal Intent (SIS).
時間枠:At 6 and 12 month
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Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal
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At 6 and 12 month
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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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
EDOR testの臨床試験
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PATHUnited States Agency for International Development (USAID); Kintampo Health Research Centre,...完了
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Centre Georges Francois Leclerc募集ステージ IV の非小細胞気管支肺癌であり、現在のフランスの推奨に従って第一選択治療の恩恵を受けるフランス
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Uniformed Services University of the Health SciencesSavvyon Diagnostics Ltd.募集