Electrodermal Hyporeactivity And Depression

Not Applicable

• Conditions: Depression Diagnosis
• Interventions: Device: EDOR test

• Registration Number: NCT02915757
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2015-03
• Status Verified: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-09-26
• Last Update Submitted: 2016-09-26
• Study First Posted: 2016-09-27
• Last Update Posted: 2016-09-27
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Depressive patients	EDOR test	EDOR test on depressed patients with or without personal history of suicidal behavior

Primary Outcome Measures

Name	Time	Method
Specificity and sensibility of the electrodermal hyporeactivity	At 6 and 12 month	Correlation between the Edor Test results and suicidal behavior

Secondary Outcome Measures

Name	Time	Method
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	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.	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).
Genetic vulnerability to suicidal behavior by polymorphism analysis in blood sample	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.
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	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).	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

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France