Electrodermal Hyporeactivity And Depression

NCT ID: NCT02915757

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-03-31

Brief 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.

Detailed 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.

Conditions

Depression Diagnosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Depressive patients

EDOR test on depressed patients with or without personal history of suicidal behavior

Group Type: EXPERIMENTAL

EDOR test

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Molise

OTHER

Sponsor Role: collaborator

EMOTRA-AB, Göteborgsvagen 74, 433 63 Sävedalen, Sweden

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Montpellier University Hospital

Montpellier, , France

Countries

France

Other Identifiers

2014-A01310-47

Identifier Type: OTHER

Identifier Source: secondary_id

UF 9464

Identifier Type: -

Identifier Source: org_study_id