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

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ClinicalTrials.gov Identifier: NCT02901769
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Suicide Other: fMRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide
Study Start Date : February 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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




Primary Outcome Measures :
  1. fMRI activation area [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901769


Contacts
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Contact: David Travers, MD 02 99 28 67 67 david.travers@chu-rennes1.fr

Locations
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France
Rennes university hospital Recruiting
Rennes, France, 35000
Principal Investigator: Davide Travers, MD         
Principal Investigator: David Travers, MD         
Sponsors and Collaborators
Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02901769     History of Changes
Other Study ID Numbers: 2011-A00944-37
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms