NCT02960191

Brief Summary

The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

3.2 years

First QC Date

August 30, 2016

Last Update Submit

November 7, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • MRI variations

    activation of specific brain areas during the procurement of a test decision

    at day 0

Study Arms (3)

healthy volunteers

OTHER

subject with no current or past personal history of psychiatric disorders and about never having carried out suicide attempt

Device: Magnetic resonance imaging (MRI)

emotional witness

OTHER

subject having had a personal history of unipolar or bipolar depressive disorder and who have never done in his life attempted suicide

Device: Magnetic resonance imaging (MRI)

patient suicide

OTHER

subject having had a personal history of unipolar or bipolar depressive disorder and having realized in his life at least one suicide attempt

Device: Magnetic resonance imaging (MRI)

Interventions

emotional witnesshealthy volunteerspatient suicide

Eligibility Criteria

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

You may qualify if:

  • right-handed
  • arm suicidal : Personal history of unipolar depressive disorder or bipolar disorder and having realized in his life at least one suicide attempt
  • arm emotional Witnesses : Personal history of unipolar depressive disorder or bipolar disorder and have never done in his life attempted suicide
  • arm healthy Witnesses : any current or past personal history of psychiatric disorders of Axis I and have never done in his life attempted suicide

You may not qualify if:

  • Cons-indications to the use of MRI
  • Existence of a past history of head trauma with loss of consciousness or neurological brain disorder or secondary neurological suffering suicidal gesture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

November 9, 2016

Study Start

December 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations