Electrodermal Hyporeactivity And Depression

NCT02915757 | Unknown

• 2 other identifiers: UF 94642014-A01310-47
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Diagnosis

Keywords

Depression; EDOR test; Electrodermal hyporeactivity

Outcome Measures

Primary Outcomes (1)

• Specificity and sensibility of the electrodermal hyporeactivity

  Correlation between the Edor Test results and suicidal behavior

  At 6 and 12 month

Secondary Outcomes (6)

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

  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)

  At 6 and 12 month

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

  At 6 and 12 month

• Genetic vulnerability to suicidal behavior by polymorphism analysis in blood sample

  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)

  At 6 and 12 month

Study Arms (1)

Depressive patients

EXPERIMENTAL

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

Device: EDOR test

Interventions

EDOR test 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

Depressive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University of Molise: collaborator
• EMOTRA-AB, Göteborgsvagen 74, 433 63 Sävedalen, Sweden: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: September 27, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)