Overview

This trial is active, not recruiting.

Condition depression diagnosis
Treatment edor test
Sponsor University Hospital, Montpellier
Collaborator University of Molise
Start date March 2015
End date March 2017
Trial size 112 participants
Trial identifier NCT02915757, 2014-A01310-47, UF 9464

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
EDOR test on depressed patients with or without personal history of suicidal behavior
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

Primary Outcomes

Measure
Specificity and sensibility of the electrodermal hyporeactivity
time frame: At 6 and 12 month

Secondary Outcomes

Measure
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: 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)
time frame: At 6 and 12 month
Electrodermal activity in depressive and suicidal patients with or without insomnia.
time frame: At 6 and 12 month
Genetic vulnerability to suicidal behavior by polymorphism analysis in blood sample
time frame: 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)
time frame: 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).
time frame: At 6 and 12 month

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Naturalistic Clinical Studies in Several Centres of Electrodermal Hyporeactivity in Adult Patients With Primary Depression
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University Hospital, Montpellier.