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Electrodermal Hyporeactivity And Depression (EUDOR-A)

26 september 2016 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

112

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Montpellier, Frankrike, 34295
        • Montpellier University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Depressive patients
EDOR test on depressed patients with or without personal history of suicidal behavior
Enhet: EDOR test

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Specificity and sensibility of the electrodermal hyporeactivity
Tidsram: At 6 and 12 month
Correlation between the Edor Test results and suicidal behavior
At 6 and 12 month

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsram: At 6 month
Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal
At 6 month
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsram: 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
Electrodermal activity in depressive and suicidal patients with or without insomnia.
Tidsram: At 6 and 12 month
Comparison of test result between patients with insomnia and patient without insomnia. Insomnia will be evaluated with the "Insomnia severity index" (ISI).
At 6 and 12 month
Genetic vulnerability to suicidal behavior by polymorphism analysis in blood sample
Tidsram: At the inclusion
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.
At the inclusion
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Risk Rescue Rating Scale (RRRS)
Tidsram: 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).
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Montpellier

Samarbetspartners

University of Molise
EMOTRA-AB, Göteborgsvagen 74, 433 63 Sävedalen, Sweden

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2015

Primärt slutförande (Förväntat)

1 mars 2017

Avslutad studie (Förväntat)

1 mars 2017

Studieregistreringsdatum

Först inskickad

20 juli 2016

Först inskickad som uppfyllde QC-kriterierna

26 september 2016

Första postat (Uppskatta)

27 september 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

27 september 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 september 2016

Senast verifierad

1 juli 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UF 9464
  • 2014-A01310-47 (Annan identifierare: Agence Nationale de sécurité des Médicaments)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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