Major Depression2BSBNCT02855918
Blood Biomarkers in Suicidal Behaviour
A study testing Blood sample for genetic purpose in people with Major Depression, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- Blood sample for genetic purpose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2016to 24 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Major Depression
- Being tested
- Blood sample for genetic purpose
- Keywords
- Psychiatry, Depressive disorder, Suicidal behavior, Genetics
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample for genetic purposeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Blood sample for genetic purpose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Secondary outcomes (15)
Modification of the expression of ADAR1a enzymes
Comparison of the profiles of ADARs expression and PDE8A editing between non suicidal and suicidal depressed patients and healthy controls
Measured: 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)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression of ADAR1b enzymes
Comparison of the profiles of ADARs expression and PDE8A editing between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression of ADAR2 enzymes
Comparison of the profiles of ADARs expression and PDE8A editing between non suicidal and suicidal depressed patients and healthy controls
Measured: 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)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Interleukins (ILs)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Chemokines (CXCLs)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Brain derived Neurotrphic factor (BDNF)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Cluster of differentiation 24 (CD24)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Three prime repair exonuclease 1 (TREX1)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Interferon stimulated gene 15 (ISG15)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Tumor necrosis factor alpha (TNF alpha)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Vascular endothelial growth factor (VEGF)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Hydroxytryptamine receptor 2A (HTR2A)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of insulin-like growth factor protein 7 (IGFB7)
Comparison between non suicidal and suicidal depressed patients and healthy controls
Measured: At the inclusion visit, 3 months and 6 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start23 Sep 2016
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855918
- Sponsor's protocol ID
- UF 9625
- Other IDs
- 2015-A01978-41
- Acronym
- 2BSB
- Status last verified
- Dec 2021
- First submitted
- 15 Jul 2016
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of the Expression of ADARs and PDE8A Editing in Suicidal Behavior
- ClinicalTrials.gov ID
- NCT02855918
- Acronym / sponsor ID
- 2BSB / UF 9625
- Conditions
- Major Depression
- Keywords
- Psychiatry, Depressive disorder, Suicidal behavior, Genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample for genetic purpose | Other | Other: Blood sample for genetic purposeAll 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample for genetic purposeAll 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. | Other | Blood sample for genetic purpose |
Primary outcome
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
15 secondary outcomes
Modification of the expression of ADAR1a enzymes
Time frame: 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)
Time frame: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression of ADAR1b enzymes
Time frame: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression of ADAR2 enzymes
Time frame: 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)
Time frame: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Interleukins (ILs)
Time frame: At the inclusion visit, 3 months and 6 months after the inclusion
Modification of the expression and RNA editing of Chemokines (CXCLs)
Time frame: At the inclusion visit, 3 months and 6 months after the inclusion
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample for genetic purpose in people with Major Depression, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021; AzTrials last refreshed its copy on 1 Nov 2026.