Molecular Genetics of Suicidal Behavior

Suicidal Behaviour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02858635
• Other study ID #: 7653
• Status: Active, not recruiting
• Phase: N/A
• First received: July 18, 2016
• Last updated: August 3, 2016
• Start date: September 2001
• Est. completion date: September 2017

Study information

• Verified date: August 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1982
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Suicidal Behaviour

Intervention

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

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Central Hospital, Nancy, France, Créteil Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of suicide attempt	occurrence of a suicide attempt will be assessed by the Columbia History Form at each visit	up to 6 months	No
Secondary	suicidal ideation	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	No
Secondary	number of suicide attempt	assessed by clinical interview	1 hour	No
Secondary	type of suicide attempt	assessed by clinical interview	1 hour	No
Secondary	lethality of suicide attempt	assessed by Risk-Rescue Rating Scale (RRRS)	1 hour	No
Secondary	anger	assessed by State-Trait Anger Expression Inventory (STAXI scale)	1 hour	No
Secondary	Impulsivity	assessed by barratt impulsiveness scale (BIS scale)	1 hour	No
Secondary	aggressiveness	assessed by buss durkee hostility inventory (BDHI)	1 hour	No
Secondary	psychological pain	assessed by Likert scale	1 hour	No