Molecular Genetics of Suicidal Behavior

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Unknown status
CT.gov ID
NCT02858635
Collaborator
Créteil Hospital (Other), Central Hospital, Nancy, France (Other)
1,982
1
1
192
10.3

Study Details

Study Description

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. 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. 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. 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. To investigate the association between events in real life (using ecological momentary assessment) and emotional response and suicidal ideation.

The investigators propose to use a multidisciplinary approach to answer these questions and, hence, be able to identify new prevention strategies for SB.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical and neuropsychological assessment, Blood and saliva samples
N/A

Detailed Description

Transversal study:

1500 patients with a personal history of suicide attempt will be recruited. Clinical, biological and neuropsychological assessments will be performed. The first objective of the study is to replicate the results already obtained regarding the association between serotonergic system genes and suicidal behaviour. The allele frequencies for different markers tested in suicidal and in control subjects with no history of suicidal behaviour will be compared. The patients that will be recruited will be compared to the control population already recruited for another project.

Prospective study: 554 patients hospitalized for a suicide attempt will will be evaluated, each 6 month, during the 2-years period of the study. Clinical, biological and neuropsychological assessments will be performed.

At the end of the inclusion visit, 60 participants will be assessed using ecological momentary assessment(ESM). They will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance.

Study Design

Study Type:
Interventional
Actual Enrollment :
1982 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Molecular Genetics of Suicidal Behavior: Study of Association Between Aggressive Impulsiveness and Genes of the Serotoninergic System
Study Start Date :
Sep 1, 2001
Anticipated Primary Completion Date :
Sep 1, 2017
Anticipated Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Suicide attempters

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

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

Outcome Measures

Primary Outcome Measures

  1. occurrence of suicide attempt [up to 6 months]

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

Secondary Outcome Measures

  1. suicidal ideation [up to 7 days]

    suicidal ideation will be assessed by scale for suicidal ideation (SSI) self-assessments (with a smartphone) by Likert scales, 5 times per day during 7 days.

  2. number of suicide attempt [1 hour]

    assessed by clinical interview

  3. type of suicide attempt [1 hour]

    assessed by clinical interview

  4. lethality of suicide attempt [1 hour]

    assessed by Risk-Rescue Rating Scale (RRRS)

  5. anger [1 hour]

    assessed by State-Trait Anger Expression Inventory (STAXI scale)

  6. Impulsivity [1 hour]

    assessed by barratt impulsiveness scale (BIS scale)

  7. aggressiveness [1 hour]

    assessed by buss durkee hostility inventory (BDHI)

  8. psychological pain [1 hour]

    assessed by Likert scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • Pregnancy

  • Not able to speak, read and understand French

  • Patient on protective measures (guardianship or trusteeship)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University hospital of Montpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier
  • Créteil Hospital
  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT02858635
Other Study ID Numbers:
  • 7653
First Posted:
Aug 8, 2016
Last Update Posted:
Aug 8, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by University Hospital, Montpellier

Study Results

No Results Posted as of Aug 8, 2016