NCT02901769

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

6 years

First QC Date

September 5, 2016

Last Update Submit

September 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • fMRI activation area

    1 day

Study Arms (4)

Depressed suicide attempters

EXPERIMENTAL

20 subjects

Other: fMRI

Depressed patients with past history of

EXPERIMENTAL

20 subjects

Other: fMRI

Depressed patients with no history of

EXPERIMENTAL

20 subjects

Other: fMRI

Healthy controls

PLACEBO COMPARATOR

20 subjects

Other: fMRI

Interventions

fMRIOTHER

two fMRI paradigms, emotional prosody recognition and decision making

Depressed patients with no history ofDepressed patients with past history ofDepressed suicide attemptersHealthy controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

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

Locations