Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide
EMODES
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 5, 2016
CompletedFirst Posted
Study publicly available on registry
September 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedSeptember 15, 2016
September 1, 2016
6 years
September 5, 2016
September 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
fMRI activation area
1 day
Study Arms (4)
Depressed suicide attempters
EXPERIMENTAL20 subjects
Depressed patients with past history of
EXPERIMENTAL20 subjects
Depressed patients with no history of
EXPERIMENTAL20 subjects
Healthy controls
PLACEBO COMPARATOR20 subjects
Interventions
two fMRI paradigms, emotional prosody recognition and decision making
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Another psychiatric trouble than depression,
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rennes university hospital
Rennes, 35000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2016
First Posted
September 15, 2016
Study Start
February 1, 2013
Primary Completion
February 1, 2019
Study Completion
February 1, 2020
Last Updated
September 15, 2016
Record last verified: 2016-09