Electrodermal Hyporeactivity And Depression (EUDOR-A)
26. september 2016 opdateret af: 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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
112
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Montpellier, Frankrig, 34295
- Montpellier University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Specificity and sensibility of the electrodermal hyporeactivity
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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)
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
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Studer store datoer
Studiestart
1. marts 2015
Primær færdiggørelse (Forventet)
1. marts 2017
Studieafslutning (Forventet)
1. marts 2017
Datoer for studieregistrering
Først indsendt
20. juli 2016
Først indsendt, der opfyldte QC-kriterier
26. september 2016
Først opslået (Skøn)
27. september 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. september 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. september 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UF 9464
- 2014-A01310-47 (Anden identifikator: Agence Nationale de sécurité des Médicaments)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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