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

NCT ID: NCT02901769

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2020-02-29

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.

Conditions

Suicide

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Depressed suicide attempters

20 subjects

Group Type: EXPERIMENTAL

fMRI

Intervention Type: OTHER

two fMRI paradigms, emotional prosody recognition and decision making

Depressed patients with past history of

20 subjects

Group Type: EXPERIMENTAL

fMRI

Intervention Type: OTHER

two fMRI paradigms, emotional prosody recognition and decision making

Depressed patients with no history of

20 subjects

Group Type: EXPERIMENTAL

fMRI

Intervention Type: OTHER

two fMRI paradigms, emotional prosody recognition and decision making

Healthy controls

20 subjects

Group Type: PLACEBO_COMPARATOR

fMRI

Intervention Type: OTHER

two fMRI paradigms, emotional prosody recognition and decision making

Interventions

fMRI

two fMRI paradigms, emotional prosody recognition and decision making

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rennes university hospital

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David Travers, MD

Role: CONTACT

david.travers@chu-rennes1.fr

02 99 28 67 67

Other Identifiers

2011-A00944-37

Identifier Type: -

Identifier Source: org_study_id