NCT01493323

Brief Summary

Suicidal behaviour (SB) represents a major public health problem, costing life in more that one million people every year worldwide. Even if SB is considered as a consequence of social adversity and depression, these stress factors are often necessary but not sufficient to explain the occurrence of a suicidal act. A preliminary study suggests that an increased perception of psychic pain during a major depressive disorder increases the risk of suicide behaviour. The investigators aimed to investigate the relationship between social exclusion (a classic trigger of psychic pain) and SB and improve our knowledge about the physiopathology of this domain.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

4.3 years

First QC Date

November 10, 2011

Last Update Submit

December 3, 2014

Conditions

Keywords

Psychic painSocial exclusionMood disordersSuicide, attemptedMagnetic Resonance Imaging, FunctionalGeneticPhysic pain

Outcome Measures

Primary Outcomes (2)

  • Cerebral regions associated with psychic pain during a major depressive disorder

    Magnetic Resonance Imaging to visualize cerebral regions associated with psychic pain during a major depressive disorder

    One day

  • Cerebral regions associated with perception of social exclusion

    Magnetic Resonance Imaging to visualize the cerebral regions associated with perception of social exclusion

    One day

Study Arms (2)

Control

EXPERIMENTAL
Behavioral: Assessment of personality traitsBehavioral: Assessment of suicidal actBehavioral: Assessment of depressionProcedure: Cyber ball gameProcedure: Iowa Gambling TaskProcedure: MicrocomputerProcedure: blood sample

Depressive attempters

EXPERIMENTAL
Behavioral: Assessment of personality traitsBehavioral: Assessment of suicidal actBehavioral: Assessment of depressionProcedure: Cyber ball gameProcedure: Iowa Gambling TaskProcedure: MicrocomputerProcedure: blood sample

Interventions

suicide behaviour , psychic pain, social exclusion, decision making...

Also known as: impulsivity, anger, anxiety, emotional lability, self-administered questionnaires
ControlDepressive attempters

suicide behaviour , psychic pain, social exclusion, decision making...

Also known as: SIS, RRRS
ControlDepressive attempters

suicide behaviour , psychic pain, social exclusion, decision making...

Also known as: BDI, HAMD-21
ControlDepressive attempters

functional neuroimaging

Also known as: fIRM
ControlDepressive attempters

functional neuroimaging

ControlDepressive attempters
MicrocomputerPROCEDURE

functional neuroimaging

Also known as: palm
ControlDepressive attempters
blood samplePROCEDURE

blood sample

ControlDepressive attempters

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Non specific criteria, for all the participants: * Woman- 18-50 years old * Non menopausal * Right-handed * Caucasian from western Europe (exception of Basque and Sardinian), for genetic purposes * Subject who signed informed consent * Able to understand the nature, the aim, and the methodology of the study and agree to cooperate during clinical and radiological evaluation Specific criteria:For depressed suicide attempters : * DSM IV criteria for major depressive disorder * Personal history of suicide attempt * No psychotropic treatment currently For depressed affective controls : * DSM IV criteria for major depressive disorder * No personal history of suicide attempt * No psychotropic treatment currently For non depressed suicide attempters : * Personal history of unipolar or bipolar mood disorder, according to DSM IV criteria * Normothymic currently (HAMD\<7) * Personal history of suicide attempt * Minimum treatment Healthy controls : * No personal history of axis I psychiatric disorders according to the MINI and the DSM IV criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

MontpellierUniversity Hopital

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Suicide, AttemptedMood DisordersSocial Isolation

Interventions

mycophenolic adenine dinucleotidePALM protein, humanBlood Specimen Collection

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorMental DisordersSocial Behavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Philippe PC Courtet, Professor(MD-PhD)

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 10, 2011

First Posted

December 15, 2011

Study Start

May 1, 2010

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations