Electrodermal Hyporeactivity And Depression (EUDOR-A)
2016년 9월 26일 업데이트: University Hospital, Montpellier
Naturalistic Clinical Studies in Several Centres of Electrodermal Hyporeactivity in Adult Patients With Primary Depression
Suicide, suicide attempts and depression are major social problems.
The present research program focuses on the relationship between electrodermal hyporeactivity, as measured by the ElectroDermal Orienting Reactivity (EDOR) Test, and suicide and suicide attempts with death intent in patients with a primary diagnosis of depression.
Electrodermal hyporeactivity has in several publications from different laboratories repeatedly been shown to have a high sensitivity (up to 97%) and high raw specificity (up to 98%) for suicide.
Such levels are unique in psychiatry.
The relationship between suicidal propensity and hyporeactivity can be considered as strongly significant.
Almost all evidence in the topic up today has been established in research settings with specific exclusion criteria for some secondary psychiatric and some somatic illnesses.
However, it is important to study the relationship between electrodermal hyporeactivity and suicide in relatively unselected patients regarding secondary psychiatric diagnoses and somatic diagnoses in a natural clinical ward situation and milieu.
A previous naturalistic study proved that a test of electrodermal hyporeactivity fits very well into the daily clinical work.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
112
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Montpellier, 프랑스, 34295
- Montpellier University Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Specificity and sensibility of the electrodermal hyporeactivity
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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)
기간: 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)
기간: 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.
기간: 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
기간: 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)
기간: 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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The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Beck Scale for Suicidal Intent (SIS).
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 3월 1일
기본 완료 (예상)
2017년 3월 1일
연구 완료 (예상)
2017년 3월 1일
연구 등록 날짜
최초 제출
2016년 7월 20일
QC 기준을 충족하는 최초 제출
2016년 9월 26일
처음 게시됨 (추정)
2016년 9월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 9월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 9월 26일
마지막으로 확인됨
2016년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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