- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02855918
Blood Biomarkers in Suicidal Behaviour (2BSB)
Modification of the Expression of ADARs and PDE8A Editing in Suicidal Behavior
Suicidal behavior (SB) is a major public health problem in France, with more than 10,000 suicides and 220,000 suicide attempts per year.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Over two years, 600 participants will be recruited:
- 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Montpêllier, France, 34295
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
No specific inclusion criteria :
- 18 to 65 years
- 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.
Specific inclusion criteria depressed suicide attempters:
- 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
- Refusal of participation
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: Blood sample for genetic purpose
All the participants performed the same evaluations and blood analysis. The study is composed of 3 groups :
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All the participants will performed the same evaluations and blood analysis :
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of the modification of the expression of Adenosine deaminases acting on RNA (ADARs) and of the editing profile of phospho-diesterase 8A (PDE8A)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Studying ADARs expression and RNA editing of genes associated with SB, including PDE8A and comparison of these results between healthy controls and depressed patients with or without history of SB
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At the inclusion visit, 3 months and 6 months after the inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modification of the expression of ADAR1a enzymes
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison of the profiles of ADARs expression and PDE8A editing between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Spindle And Kinetochore Associated protein 2 (SKA2)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression of ADAR1b enzymes
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison of the profiles of ADARs expression and PDE8A editing between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression of ADAR2 enzymes
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison of the profiles of ADARs expression and PDE8A editing between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Spermidine/Spermine N1-Acetyltransferase 1 (SAT1)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Interleukins (ILs)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Chemokines (CXCLs)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Brain derived Neurotrphic factor (BDNF)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Cluster of differentiation 24 (CD24)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Three prime repair exonuclease 1 (TREX1)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Interferon stimulated gene 15 (ISG15)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Tumor necrosis factor alpha (TNF alpha)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Vascular endothelial growth factor (VEGF)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of Hydroxytryptamine receptor 2A (HTR2A)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Modification of the expression and RNA editing of insulin-like growth factor protein 7 (IGFB7)
Time Frame: At the inclusion visit, 3 months and 6 months after the inclusion
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Comparison between non suicidal and suicidal depressed patients and healthy controls
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At the inclusion visit, 3 months and 6 months after the inclusion
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF 9625
- 2015-A01978-41 (OTHER: Agence Nationale de Sécurité des Médicaments)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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