NCT02858635

Brief Summary

Suicide is a major health problem that causes annually a million death worldwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. According to this model, individuals who carry a suicidal act when subjected to stress factors (environmental stress, depression, substance ...) are those which have a specific vulnerability.These vulnerabilities can be considered as clinical parameters (propensity to despair, aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly underpinned by genetic factors. The interest of current researches is to identify biomarkers that will improve the opportunities for early identification of subject with a risk for SB. The four goals of this project are in the continuity of previous works team:

  1. 1.To determine whether combinations of the main serotonin-related genes may better contribute to the vulnerability to SB, than when they are considered independently.
  2. 2.To assess whether the associations between these genes and SB are modulated by childhood trauma, life events and stress response associated with these environmental factors.
  3. 3.To test the value of combined clinical, neuropsychological and genetic factor for suicide prevention, in a prospective study, in particularity impulsivity and gene gene interaction.
  4. 4.To investigate the association between events in real life (using ecological momentary assessment) and emotional response and suicidal ideation.

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
1,982

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2001

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

September 1, 2001

Completed
14.9 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

16 years

First QC Date

July 18, 2016

Last Update Submit

August 3, 2016

Conditions

Suicidal Behaviour

Keywords

Suicidal behaviourImpulsivityGeneticsSerotonin

Outcome Measures

Primary Outcomes (1)

  • occurrence of suicide attempt

    occurrence of a suicide attempt will be assessed by the Columbia History Form at each visit

    up to 6 months

Secondary Outcomes (8)

  • suicidal ideation

    up to 7 days

  • number of suicide attempt

    1 hour

  • type of suicide attempt

    1 hour

  • lethality of suicide attempt

    1 hour

  • anger

    1 hour

  • +3 more secondary outcomes

Study Arms (1)

Suicide attempters

EXPERIMENTAL

Clinical and neuropsychological assessment. Blood and saliva samples in order to answer objectives study.

Other: Clinical and neuropsychological assessment, Blood and saliva samples

Interventions

Clinical and neuropsychological assessment, Blood and saliva samplesOTHER

Clinical and neuropsychological assessment: impulsivity, aggressiveness, psychological pain, angor with specific scales and smartphone.

Suicide attempters

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • personal history of suicide attempt
  • French Caucasian Western Europe and specifically have all four grandparents from a country in Western Europe (for genetics purposes)
  • able to understand nature, aims, and methodology oh the study
  • do not emphasize to leave during the time-study.

You may not qualify if:

  • Pregnancy
  • Not able to speak, read and understand French
  • Patient on protective measures (guardianship or trusteeship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Impulsive Behavior

Interventions

Neuropsychological TestsBlood Specimen Collection

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 8, 2016

Study Start

September 1, 2001

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 8, 2016

Record last verified: 2016-08

Locations

FR(1)