Blood Biomarkers in Suicidal Behaviour

NCT02855918 | Completed

• 2 other identifiers: UF 96252015-A01978-41
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depression

Keywords

Psychiatry; Depressive disorder; Suicidal behavior; Genetics

Outcome Measures

Primary Outcomes (1)

• Evolution of the modification of the expression of Adenosine deaminases acting on RNA (ADARs) and of the editing profile of phospho-diesterase 8A (PDE8A)

  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

  At the inclusion visit, 3 months and 6 months after the inclusion

Secondary Outcomes (15)

• Modification of the expression of ADAR1a enzymes

  At the inclusion visit, 3 months and 6 months after the inclusion

• Modification of the expression and RNA editing of Spindle And Kinetochore Associated protein 2 (SKA2)

  At the inclusion visit, 3 months and 6 months after the inclusion

• Modification of the expression of ADAR1b enzymes

  At the inclusion visit, 3 months and 6 months after the inclusion

• Modification of the expression of ADAR2 enzymes

  At the inclusion visit, 3 months and 6 months after the inclusion

• Modification of the expression and RNA editing of Spermidine/Spermine N1-Acetyltransferase 1 (SAT1)

  At the inclusion visit, 3 months and 6 months after the inclusion

Study Arms (1)

Blood sample for genetic purpose

OTHER

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

Other: Blood sample for genetic purpose

Interventions

Blood sample for genetic purpose OTHER

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.

Blood sample for genetic purpose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Refusal of participation
• Deprived of liberty Subject (by judicial or administrative decision)
• Subject protected by law (guardianship)
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier: collaborator

Study Sites (1)

University Hospital

Montpêllier, 34295, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 4, 2016
• Study Start: September 23, 2016
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)