- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02858635
Molecular Genetics of Suicidal Behavior
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:
- To determine whether combinations of the main serotonin-related genes may better contribute to the vulnerability to SB, than when they are considered independently.
- 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.
- 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.
- 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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Montpellier, France, 34295
- University Hospital of Montpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Clinical and neuropsychological assessment: impulsivity, aggressiveness, psychological pain, angor with specific scales and smartphone.
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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
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up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
suicidal ideation
Time Frame: up to 7 days
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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.
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up to 7 days
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number of suicide attempt
Time Frame: 1 hour
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assessed by clinical interview
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1 hour
|
type of suicide attempt
Time Frame: 1 hour
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assessed by clinical interview
|
1 hour
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lethality of suicide attempt
Time Frame: 1 hour
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assessed by Risk-Rescue Rating Scale (RRRS)
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1 hour
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anger
Time Frame: 1 hour
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assessed by State-Trait Anger Expression Inventory (STAXI scale)
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1 hour
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Impulsivity
Time Frame: 1 hour
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assessed by barratt impulsiveness scale (BIS scale)
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1 hour
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aggressiveness
Time Frame: 1 hour
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assessed by buss durkee hostility inventory (BDHI)
|
1 hour
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psychological pain
Time Frame: 1 hour
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assessed by Likert scale
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1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7653
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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