Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide (EMODES)

September 9, 2016 updated by: Rennes University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Recruiting
        • Rennes University Hospital
        • Principal Investigator:
          • Davide Travers, MD
        • Principal Investigator:
          • David Travers, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Depressed suicide attempters
20 subjects
Other: fMRI
two fMRI paradigms, emotional prosody recognition and decision making
Experimental: Depressed patients with past history of
20 subjects
Other: fMRI
two fMRI paradigms, emotional prosody recognition and decision making
Experimental: Depressed patients with no history of
20 subjects
Other: fMRI
two fMRI paradigms, emotional prosody recognition and decision making
Placebo Comparator: Healthy controls
20 subjects
Other: fMRI
two fMRI paradigms, emotional prosody recognition and decision making

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fMRI activation area
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00944-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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