Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide

Suicide Clinical Trial

— EMODES  

Official title:

Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02901769
• Other study ID #: 2011-A00944-37
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2016
• Last updated: September 9, 2016
• Start date: February 2013
• Est. completion date: February 2020

Study information

• Verified date: September 2016
• Source: Rennes University Hospital
• Contact: David Travers, MD
• Phone: 02 99 28 67 67
• Email: david.travers[@]chu-rennes1.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Suicide is known to be frequent in depression, and in most of the psychiatric diseases. But as it can occur in patients with no psychiatric illness and doesn't occur in every patients with psychiatric illness, it has to be considered henceforth as a specific vulnerability.

This trial will study two fMRI paradigms, emotional prosody recognition and decision making, in order to characterize emotional and cognitive trait factors in a population of patients vulnerable to suicide. Four different groups will be constituted : depressed suicide attempters, depressed patients with past history of suicidal acts, depressed patients with no history of suicidal acts and healthy controls.

The main goal will be to correlate fMRI activation during the two paradigms in subjects vulnerable to suicide. The secondary goals will be to characterize emotional and cognitive trait factors in these subjects, to demonstrate that those characteristics are independent from depression and to correlate these trait factors with socio-demographic and clinical features with fMRI activations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Right-handed,

• Depressed suicide attempters for the first group,

• Depressed patients with past history of suicidal acts for the second group,

• Depressed patients with no history of suicidal acts for the third group,

• Healthy controls for the fourth group.

Exclusion Criteria:

• Another psychiatric trouble than depression,

• Another psychotrope treatment than SSRI/SNRI and/or benzodiazepine at inclusion and/or one month before,

• For the first and secand groups : more than fous suicidals acts within the past 3 years,

• Deficits that do not allow test realisation (visual audition troubles, cognitif deficits,

• Prosopagnosia,

• Pregnancy,

• Severe central nervous system disease or somatic disease,

• MRI contra-indication,

• Major benefiting from a legal protective measure,

• No coverage care.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Suicide

Intervention

Other:
• fMRI
two fMRI paradigms, emotional prosody recognition and decision making

Locations

Country	Name	City	State
France	Rennes university hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI activation area		1 day	No