Molecular Genetics of Suicidal Behavior

August 3, 2016 updated by: University Hospital, Montpellier

Molecular Genetics of Suicidal Behavior: Study of Association Between Aggressive Impulsiveness and Genes of the Serotoninergic System

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

1982

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montpellier, France, 34295
        • University Hospital of Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suicide attempters
Clinical and neuropsychological assessment. Blood and saliva samples in order to answer objectives study.
Clinical and neuropsychological assessment: impulsivity, aggressiveness, psychological pain, angor with specific scales and smartphone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of suicide attempt
Time Frame: up to 6 months
occurrence of a suicide attempt will be assessed by the Columbia History Form at each visit
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
suicidal ideation
Time Frame: 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.
up to 7 days
number of suicide attempt
Time Frame: 1 hour
assessed by clinical interview
1 hour
type of suicide attempt
Time Frame: 1 hour
assessed by clinical interview
1 hour
lethality of suicide attempt
Time Frame: 1 hour
assessed by Risk-Rescue Rating Scale (RRRS)
1 hour
anger
Time Frame: 1 hour
assessed by State-Trait Anger Expression Inventory (STAXI scale)
1 hour
Impulsivity
Time Frame: 1 hour
assessed by barratt impulsiveness scale (BIS scale)
1 hour
aggressiveness
Time Frame: 1 hour
assessed by buss durkee hostility inventory (BDHI)
1 hour
psychological pain
Time Frame: 1 hour
assessed by Likert scale
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 7653

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Suicidal Behaviour

Clinical Trials on Clinical and neuropsychological assessment, Blood and saliva samples

3
Subscribe