Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
2016-09-23
2020-06-24
Brief Summary
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According to the commonly accepted model for understanding suicidal behavior, 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. Numerous scientific studies, including post-mortem studies of the brains of suicide completers, have established a link between dysregulation of the ribonucleic acids editing (RNA) of certain genes, the enzymatic activity of Adenosine deaminases acting on RNA (ADARS) responsible for this edition and suicidal behavior. A prospective study is needed to quantify and qualify in the blood of depressed patients (with or without a history of suicide) and healthy controls, the editing changes and the expression and alteration of the activity of ADARS.
Detailed Description
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* 225 subjects with current major depressive episode and an history of suicide attempt (depressed suicide attempters)
* 225 subjects with current major depressive episode but with no personal history of suicide attempt (affective controls)
* 150 subjects with no history of psychopathology whole life (healthy controls)
Each patient will attend a total of 3visits during a follow-up period of 6 months +/- 15 days (inclusion, visit at 3 and 6 months).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Blood sample for genetic purpose
All the participants performed the same evaluations and blood analysis.
The study is composed of 3 groups :
* depressed patients with an history of suicide attempt
* depressed patients without any history of suicide attempt
* healthy controls without any history of psychopathology
Blood sample for genetic purpose
All the participants will performed the same evaluations and blood analysis :
* A clinical assessment by psychiatrist
* Self report questionnaires for the assessment of a potential mood disorder and history of SB, moral/physical pain, personality traits…
* A neuropsychological assessment for the evaluations of cognitive performances
* A routine blood sampling to the realization of a standard blood test
* A specific blood sampling (PAXgene® tubes) to extract total RNA of blood cells and measure the expression of ADARS RNA and editing of the PDE8A transcript.
Interventions
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Blood sample for genetic purpose
All the participants will performed the same evaluations and blood analysis :
* A clinical assessment by psychiatrist
* Self report questionnaires for the assessment of a potential mood disorder and history of SB, moral/physical pain, personality traits…
* A neuropsychological assessment for the evaluations of cognitive performances
* A routine blood sampling to the realization of a standard blood test
* A specific blood sampling (PAXgene® tubes) to extract total RNA of blood cells and measure the expression of ADARS RNA and editing of the PDE8A transcript.
Eligibility Criteria
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Inclusion Criteria
* Subject who signed the informed consent
* Able to understand the nature, purpose and methodology of the study
* Able to understand and perform the clinical and neuropsychological evaluations.
* Subject whose primary psychiatric diagnosis is a major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders -5 (DSM-5) criteria
* Personal history of suicide attempt
affective controls:
* Subject whose primary psychiatric diagnosis is a major depressive episode according to DSM-5 criteria
* No personal history of suicide attempt
healthy controls:
* No personal history of psychiatric disorders (Axis I ) defined by the Mini International Neuropsychiatric Interview (MINI) according to the DSM-5 criteria
* No history of suicide attempt
Exclusion Criteria
* Deprived of liberty Subject (by judicial or administrative decision)
* Subject protected by law (guardianship)
* Subject exclusion period in relation to another protocol
* Subject is not affiliated to a social security scheme, beneficiary or not such a plan
* Subject for which the maximum annual amount of allowances of € 4,500 has been reached
* Pregnant women
* Breastfeeding Women
18 Years
65 Years
ALL
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier
UNKNOWN
University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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University Hospital
Montpêllier, , France
Countries
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Other Identifiers
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2015-A01978-41
Identifier Type: OTHER
Identifier Source: secondary_id
UF 9625
Identifier Type: -
Identifier Source: org_study_id