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Electrodermal Hyporeactivity And Depression (EUDOR-A)

Primary Purpose

Depression Diagnosis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

EDOR test

About this trial

This is an interventional diagnostic trial for Depression Diagnosis focused on measuring Depression, EDOR test, Electrodermal hyporeactivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Montpellier University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Depressive patients

Arm Description

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

Outcomes

Primary Outcome Measures

Specificity and sensibility of the electrodermal hyporeactivity

Correlation between the Edor Test results and suicidal behavior

Secondary Outcome Measures

The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)

Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal

The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)

Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal

Electrodermal activity in depressive and suicidal patients with or without insomnia.

Comparison of test result between patients with insomnia and patient without insomnia. Insomnia will be evaluated with the "Insomnia severity index" (ISI).

Genetic vulnerability to suicidal behavior by polymorphism analysis in blood sample

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.

The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Risk Rescue Rating Scale (RRRS)

Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal

The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Beck Scale for Suicidal Intent (SIS).

Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal

Full Information

NCT ID

NCT02915757

First Posted

July 20, 2016

Last Updated

September 26, 2016

Sponsor

University Hospital, Montpellier

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02915757

Brief Title

Electrodermal Hyporeactivity And Depression

Acronym

EUDOR-A

Official Title

Naturalistic Clinical Studies in Several Centres of Electrodermal Hyporeactivity in Adult Patients With Primary Depression

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression Diagnosis

Keywords

Depression, EDOR test, Electrodermal hyporeactivity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Depressive patients

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

EDOR test

Intervention Description

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 Outcome Measure Information:

Title

Specificity and sensibility of the electrodermal hyporeactivity

Description

Correlation between the Edor Test results and suicidal behavior

Time Frame

At 6 and 12 month

Secondary Outcome Measure Information:

Title

The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)

Description

Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal

Time Frame

At 6 month

Title

The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)

Description

Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal

Time Frame

At 6 and 12 month

Title

Electrodermal activity in depressive and suicidal patients with or without insomnia.

Description

Comparison of test result between patients with insomnia and patient without insomnia. Insomnia will be evaluated with the "Insomnia severity index" (ISI).

Time Frame

At 6 and 12 month

Title

Genetic vulnerability to suicidal behavior by polymorphism analysis in blood sample

Description

Time Frame

At the inclusion

Title

The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Risk Rescue Rating Scale (RRRS)

Description

Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal

Time Frame

At 6 and 12 month

Title

The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Beck Scale for Suicidal Intent (SIS).

Description

Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal

Time Frame

At 6 and 12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Montpellier University Hospital

City

Montpellier

ZIP/Postal Code

34295

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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