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Completed

NCT Number: NCT02855918

Blood Biomarkers in Suicidal Behaviour

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.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Montpêllier, 34295, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

    Time frame: At the inclusion visit, 3 months and 6 months after the inclusion

    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

Secondary outcomes

  1. Modification of the expression of ADAR1a enzymes

    Time frame: At the inclusion visit, 3 months and 6 months after the inclusion

    Comparison of the profiles of ADARs expression and PDE8A editing between non suicidal and suicidal depressed patients and healthy controls

  2. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  3. Modification of the expression of ADAR1b enzymes

    Time frame: At the inclusion visit, 3 months and 6 months after the inclusion

    Comparison of the profiles of ADARs expression and PDE8A editing between non suicidal and suicidal depressed patients and healthy controls

  4. Modification of the expression of ADAR2 enzymes

    Time frame: At the inclusion visit, 3 months and 6 months after the inclusion

    Comparison of the profiles of ADARs expression and PDE8A editing between non suicidal and suicidal depressed patients and healthy controls

  5. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  6. Modification of the expression and RNA editing of Interleukins (ILs)

    Time frame: At the inclusion visit, 3 months and 6 months after the inclusion

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  7. Modification of the expression and RNA editing of Chemokines (CXCLs)

    Time frame: At the inclusion visit, 3 months and 6 months after the inclusion

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  8. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  9. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  10. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  11. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  12. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  13. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  14. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

  15. 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

    Comparison between non suicidal and suicidal depressed patients and healthy controls

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier

Registry information

Official study title

Modification of the Expression of ADARs and PDE8A Editing in Suicidal Behavior

Acronym: 2BSB

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2016
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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