SuicideIBBBiSNCT06047613
Inflammation and Blood Brain Barrier Integrity as Biomarkers of Suicidal Behavior
A study testing Blood samples, Hetero-questionnaires and auto-questionnaires and Magnetic Resonance Imaging (MRI) in people with Suicide and Depression, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in microglial activation in the brain tissue of suicide victims. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Depression
- What is being tested?
- Blood samples, Hetero-questionnaires and auto-questionnaires and Magnetic Resonance Imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2023to Oct 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Common inclusion criteria:
- Aged between 18 and 55 years old,
- Affiliated to a French National Social Security System
- Able to understand the nature, purpose and methodology of the study
- Able to give written informed consent
Specific inclusion criteria
Suicide attempters:
- Subject with a main psychiatric diagnosis of current major depressive episode according to DSM-5 criteria (the existence of psychiatric comorbidities is not a non-inclusion criterion)
- Subject with a recent history of proven suicide attempt (within the 8 days before inclusion)
- Subject with a history of maximum 2 previous lifetime proven SA
Affective controls:
- Subject with a main psychiatric diagnosis of current major depressive episode according to DSM-5 criteria (the existence of psychiatric comorbidities is not a non-inclusion criterion),
- Subject without any lifetime history suicidal behavior (proven, interrupted or aborted)
Healthy controls:
- Subject who have no current or past personal history of psychiatric disorders according to DSM5 criteria.
Non inclusion criteria
- History of psychotic disorders
- Diagnostic of illicit substance / alcohol use disorder within the last 6 months
- Current inflammation-related symptoms including fever and infectious or inflammatory disease
- Severe symptomatic or unstable medical condition (e.g., unstable endocrine or cardiovascular disease)
- Medical disorders affecting CNS function (e.g., history of severe head trauma, epilepsy, tumor)
- Current use of specific medications known to affect the immune system, such as corticosteroids, non-steroid anti-inflammatory drugs, aspirin and statins
- Contraindication to MRI or impossibility to assess, or doubt about a contraindication to the MRI: metallic artificial heart valve, pacemaker, cerebrovascular clips ferromagnetic materials, metallic foreign body that can be mobilized, in particular cerebral or intraocular, prosthesis ferromagnetic, impossibility of absolute immobility in supine position, claustrophobia.
- Vaccination in the last month
- Law protected or deprived of liberty subject
- Pregnant and breastfeeding women
- BMI > 30 kg/m2
- Having reached 6000€ annual compensation for participating to clinical trials
- Being in exclusion period for another study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital
Montpellier, 34295
Jessica DALAUDIERE, +33499614569, jessica.dalaudiere@chu-montpellier.fr
About this study
Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in microglial activation in the brain tissue of suicide victims. However the relationship between peripheral and central inflammation in suicide is probably mediated by complex biological processes that are yet elucidated. An increase of blood S100B levels (biomarker of neurovascular damage; PMID 14530574) has been reported in adolescents with suicidal ideation vs. controls and independently of psychiatric disorder.
The investigators hypothesize that peripheral inflammation may alter the blood brain barrier, which normally acts as a filter to ensure proper neuronal functioning, in suicidal patients.
They propose to investigate peripheral inflammation, neurovascular permeability and miRNAs in suicidal behavior pathophysiology as biomarkers of suicidal behavior in depression
Read the detailed description
150 participants will be enrolled, divided into 3 groups:
- 50 Suicide attempters, i.e. currently depressed patients with a suicide attempt within the 8 last days (with a maximal lifetime number of 3 previous suicide attempts, including the most recent);
- 50 Affective controls, i.e. currently depressed patients without any lifetime history of suicide attempt;
- 50 Healthy controls (age- and gender-matched to patients' groups) with no lifetime history of psychiatric disorders.
The protocol includes two visits for patients (suicide attempters and affective controls) and only one visit (inclusion) for healthy controls.
The first visit is the inclusion visit (Day 0-Day 8). Day 0 is the date of the last suicide attempt for the suicide attempters group and the date of signature of the consent for the affective control and healthy control groups. All the visit exams will be performed within 8 days after Day 0.
The second visit takes place one month +/- one week after inclusion. At each visit, a clinical assessment will be performed to characterise psychopathology and suicidal characteristics. Blood samples will be obtained in order to measure inflammatory markers. An MRI will be performed on order to study white matter microstructure and brain functional connectivity networks.
- Conditions
- Suicide, Depression
- Being tested
- Blood samples, Hetero-questionnaires and auto-questionnaires, Magnetic Resonance Imaging (MRI)
- Keywords
- suicide, depression
- Medical subject headings
- Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Blood samples will be collected at both visit between 8:30 a.m. and 10 a.m. and fasting from midnight.
Hetero-questionnaires and auto-questionnairesOther
Questionnaires will be administrated at both visits to assess the suicide spectrum, the depression level and some personality traits.
Heteroquestionnaires will be administrated during a clinical interview (1h) conducted by a psychiatrist or psychologist. Autoquestionnaires (45 min) will be completed by the participant himself.
Magnetic Resonance Imaging (MRI)Other
MRI will be processed (at both visits for patients and at inclusion visit for healthy controls) to study between groups white matter microstructure and brain functional connectivity networks
| Study group | Role | What they receive |
|---|---|---|
| Suicide attempters | Experimental | Currently depressed patients with a suicide attempt within the 8 last days (with a maximal lifetime number of 3 previous suicide attempt including the most recent ); Receives: Biological: Blood samples; Other: Hetero-questionnaires and auto-questionnaires; Other: Magnetic Resonance Imaging (MRI) |
| Affective controls | Active comparator | Currently depressed patients without any lifetime history of suicide attempt Receives: Biological: Blood samples; Other: Hetero-questionnaires and auto-questionnaires; Other: Magnetic Resonance Imaging (MRI) |
| Healthy controls | Active comparator | Participants with no lifetime history of psychiatric disorders Receives: Biological: Blood samples; Other: Hetero-questionnaires and auto-questionnaires; Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.
Measured: At inclusion
Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.
Measured: At 1 month follow-up
Secondary outcomes (42)
Cytokines' concentration by multiplex ELISA (pg/ml)
C-C motif chemokine ligand (CCL)2, CCL3, CCL4, CCL11, CCL13, CCL17, CCL20, CCL22, CCL26, C-X-C motif chemokine ligand (CXCL)10, Interleukin (IL)-1α, IL 1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23 p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL- 27, IL-31, interferon (IFN)-γ, Tumor Necrosis Factor ðTNFÞ α, TNF ß and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Measured: At inclusion
Cytokines' concentration by multiplex ELISA (pg/ml)
C-C motif chemokine ligand (CCL)2, CCL3, CCL4, CCL11, CCL13, CCL17, CCL20, CCL22, CCL26, C-X-C motif chemokine ligand (CXCL)10, Interleukin (IL)-1α, IL 1ß, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23 p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL- 27, IL-31, interferon (IFN)-γ, Tumor Necrosis Factor ðTNFÞ α, TNF ß and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Measured: At 1 month follow-up
Specific proteins measurement (pg/ml)
Specific proteins measurement (i.e. GFAP, NFL, UHC-L1, sGPR56, S100B, MBP and related proteins) using digital or classical ELISA or western blot
Measured: At inclusion
Specific proteins measurement (pg/ml)
Specific proteins measurement (i.e. GFAP, NFL, UHC-L1, sGPR56, S100B, MBP and related proteins) using digital or classical ELISA or western blot
Measured: At 1 month follow-up
FACS analysis on fresh blood
Determination of the number of white cells
Measured: At inclusion
FACS analysis on fresh blood
Determination of the number of white cells
Measured: At 1 month follow-up
FACS analysis on fresh blood
Description of the phenotype of white cells
Measured: At inclusion
FACS analysis on fresh blood
Description of the phenotype of white cells
Measured: At 1 month follow-up
FACS analysis on fresh blood
Percentage of cellular inflammatory marker
Measured: At inclusion
FACS analysis on fresh blood
Percentage of cellular inflammatory marker
Measured: At 1 month follow-up
Extraction of small and long RNA
Use of RNA-seq, RT-qPCR and digital PCR to quantify RNA
Measured: At inclusion
Extraction of small and long RNA
Use of RNA-seq, RT-qPCR and digital PCR to quantify RNA
Measured: At 1 month follow-up
Test of the capacity of leukocytes isolated from patients to provoke vascular inflammation and BBB permeabilization
These experiments will be performed using an in vitro model of vascular cell co-culture. The reactivity of leukocytes to pro-inflammatory challenges and cytokines will be tested.
Measured: At inclusion
Test of the capacity of leukocytes isolated from patients to provoke vascular inflammation and BBB permeabilization
These experiments will be performed using an in vitro model of vascular cell co-culture. The reactivity of leukocytes to pro-inflammatory challenges and cytokines will be tested.
Measured: At 1 month follow-up
White matter microstructure analysis
The ihMT (ihMTR) and MT (MTR) ratios will be performed in the apparently normal white and gray matter regions from regional white matter and gray matter atlases
Measured: At inclusion
White matter microstructure analysis
The ihMT (ihMTR) and MT (MTR) ratios will be performed in the apparently normal white and gray matter regions from regional white matter and gray matter atlases
Measured: At 1 month follow-up
White matter microstructure analysis
Value of the fraction of anisotropy (FA) along the skeleton of the Tract-based spatial statistics TBSS
Measured: At inclusion
White matter microstructure analysis
Value of the fraction of anisotropy (FA) along the skeleton of the Tract-based spatial statistics TBSS
Measured: At 1 month follow-up
White matter microstructure analysis
Extraction by anatomical region of FA, mean, axial and radial diffusivity [FSL software)
Measured: At inclusion
White matter microstructure analysis
Extraction by anatomical region of FA, mean, axial and radial diffusivity [FSL software)
Measured: At 1 month follow-up
White matter microstructure analysis
Value of diffusion of blood water D* (pseudocoefficient =perfusive composante) from different region based on regional atlases
Measured: At inclusion
White matter microstructure analysis
Value of diffusion of blood water D* (pseudocoefficient =perfusive composante) from different region based on regional atlases
Measured: At 1 month follow-up
White matter microstructure analysis
Value of diffusion of the tissue (ADC) from different region based on regional atlases
Measured: At inclusion
White matter microstructure analysis
Value of diffusion of the tissue (ADC) from different region based on regional atlases
Measured: At 1 month follow-up
White matter microstructure analysis
Value of fraction of perfusion fD* ( incoherent blood signal divided by total incoherent signal) from different region based on regional atlases
Measured: At inclusion
White matter microstructure analysis
Value of fraction of perfusion fD* ( incoherent blood signal divided by total incoherent signal) from different region based on regional atlases
Measured: At 1 month follow-up
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Regional homogeneity
Measured: At inclusion
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Regional homogeneity
Measured: At 1 month follow-up
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Amplitude of low frequency fluctuations
Measured: At inclusion
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Amplitude of low frequency fluctuations
Measured: At 1 month follow-up
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Functional homotopy
Measured: At inclusion
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Functional homotopy
Measured: At 1 month follow-up
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Graph theory metrics
Measured: At inclusion
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Graph theory metrics
Measured: At 1 month follow-up
Cerebral morphometric extraction (3DT1): automatic segmentation
Evaluation of the volume from cerebral anatomical atlas
Measured: At inclusion
Cerebral morphometric extraction (3DT1): automatic segmentation
Evaluation of the volume from cerebral anatomical atlas
Measured: At 1 month follow-up
Cerebral morphometric extraction (3DT1): automatic segmentation
Evaluation of the surface from cerebral anatomical atlas
Measured: At inclusion
Cerebral morphometric extraction (3DT1): automatic segmentation
Evaluation of the surface from cerebral anatomical atlas
Measured: At 1 month follow-up
Cerebral morphometric extraction (3DT1): automatic segmentation
Evaluation of the cortical thickness from cerebral anatomical atlas
Measured: At inclusion
Cerebral morphometric extraction (3DT1): automatic segmentation
Evaluation of the cortical thickness from cerebral anatomical atlas
Measured: At 1 month follow-up
Cerebral blood analysis
Extraction of blood flow values from 3D PCASL acquisition from vascular atlas
Measured: At inclusion
Cerebral blood analysis
Extraction of blood flow values from 3D PCASL acquisition from vascular atlas
Measured: At 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start5 Oct 2023
- Primary completionMay 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047613
- Sponsor's protocol ID
- RECHMPL22_0103
- Acronym
- IBBBiS
- Status last verified
- Nov 2023
- First submitted
- 21 Jul 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Blood Brain Barrier Integrity as Biomarkers of Suicidal Behavior
- ClinicalTrials.gov ID
- NCT06047613
- Acronym / sponsor ID
- IBBBiS / RECHMPL22_0103
- Conditions
- Suicide, Depression
- Keywords
- suicide, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- 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.
Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in microglial activation in the brain tissue of suicide victims. However the relationship between peripheral and central inflammation in suicide is probably mediated by complex biological processes that are yet elucidated. An increase of blood S100B levels (biomarker of neurovascular damage; PMID 14530574) has been reported in adolescents with suicidal ideation vs. controls and independently of psychiatric disorder.
The investigators hypothesize that peripheral inflammation may alter the blood brain barrier, which normally acts as a filter to ensure proper neuronal functioning, in suicidal patients.
They propose to investigate peripheral inflammation, neurovascular permeability and miRNAs in suicidal behavior pathophysiology as biomarkers of suicidal behavior in depression
Detailed description
150 participants will be enrolled, divided into 3 groups:
- 50 Suicide attempters, i.e. currently depressed patients with a suicide attempt within the 8 last days (with a maximal lifetime number of 3 previous suicide attempts, including the most recent);
- 50 Affective controls, i.e. currently depressed patients without any lifetime history of suicide attempt;
- 50 Healthy controls (age- and gender-matched to patients' groups) with no lifetime history of psychiatric disorders.
The protocol includes two visits for patients (suicide attempters and affective controls) and only one visit (inclusion) for healthy controls.
The first visit is the inclusion visit (Day 0-Day 8). Day 0 is the date of the last suicide attempt for the suicide attempters group and the date of signature of the consent for the affective control and healthy control groups. All the visit exams will be performed within 8 days after Day 0.
The second visit takes place one month +/- one week after inclusion. At each visit, a clinical assessment will be performed to characterise psychopathology and suicidal characteristics. Blood samples will be obtained in order to measure inflammatory markers. An MRI will be performed on order to study white matter microstructure and brain functional connectivity networks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suicide attempters | Experimental | Biological: Blood samples, Other: Hetero-questionnaires and auto-questionnaires, Other: Magnetic Resonance Imaging (MRI)Currently depressed patients with a suicide attempt within the 8 last days (with a maximal lifetime number of 3 previous suicide attempt including the most recent ); |
| Affective controls | Active comparator | Biological: Blood samples, Other: Hetero-questionnaires and auto-questionnaires, Other: Magnetic Resonance Imaging (MRI)Currently depressed patients without any lifetime history of suicide attempt |
| Healthy controls | Active comparator | Biological: Blood samples, Other: Hetero-questionnaires and auto-questionnaires, Other: Magnetic Resonance Imaging (MRI)Participants with no lifetime history of psychiatric disorders |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 samplesBlood samples will be collected at both visit between 8:30 a.m. and 10 a.m. and fasting from midnight. | Biological | Affective controls, Healthy controls, Suicide attempters |
| Hetero-questionnaires and auto-questionnairesQuestionnaires will be administrated at both visits to assess the suicide spectrum, the depression level and some personality traits. Heteroquestionnaires will be administrated during a clinical interview (1h) conducted by a psychiatrist or psychologist. Autoquestionnaires (45 min) will be completed by the participant himself. | Other | Affective controls, Healthy controls, Suicide attempters |
| Magnetic Resonance Imaging (MRI)MRI will be processed (at both visits for patients and at inclusion visit for healthy controls) to study between groups white matter microstructure and brain functional connectivity networks | Other | Affective controls, Healthy controls, Suicide attempters |
Primary outcome
Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.
Time frame: At inclusion
Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions.
Time frame: At 1 month follow-up
42 secondary outcomes
Cytokines' concentration by multiplex ELISA (pg/ml)
Time frame: At inclusion
Cytokines' concentration by multiplex ELISA (pg/ml)
Time frame: At 1 month follow-up
Specific proteins measurement (pg/ml)
Time frame: At inclusion
Specific proteins measurement (pg/ml)
Time frame: At 1 month follow-up
FACS analysis on fresh blood
Time frame: At inclusion
FACS analysis on fresh blood
Time frame: At 1 month follow-up
FACS analysis on fresh blood
Time frame: At inclusion
FACS analysis on fresh blood
Time frame: At 1 month follow-up
FACS analysis on fresh blood
Time frame: At inclusion
FACS analysis on fresh blood
Time frame: At 1 month follow-up
Extraction of small and long RNA
Time frame: At inclusion
Extraction of small and long RNA
Time frame: At 1 month follow-up
Test of the capacity of leukocytes isolated from patients to provoke vascular inflammation and BBB permeabilization
Time frame: At inclusion
Test of the capacity of leukocytes isolated from patients to provoke vascular inflammation and BBB permeabilization
Time frame: At 1 month follow-up
White matter microstructure analysis
Time frame: At inclusion
White matter microstructure analysis
Time frame: At 1 month follow-up
White matter microstructure analysis
Time frame: At inclusion
White matter microstructure analysis
Time frame: At 1 month follow-up
White matter microstructure analysis
Time frame: At inclusion
White matter microstructure analysis
Time frame: At 1 month follow-up
White matter microstructure analysis
Time frame: At inclusion
White matter microstructure analysis
Time frame: At 1 month follow-up
White matter microstructure analysis
Time frame: At inclusion
White matter microstructure analysis
Time frame: At 1 month follow-up
White matter microstructure analysis
Time frame: At inclusion
White matter microstructure analysis
Time frame: At 1 month follow-up
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Time frame: At inclusion
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Time frame: At 1 month follow-up
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Time frame: At inclusion
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Time frame: At 1 month follow-up
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Time frame: At inclusion
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Time frame: At 1 month follow-up
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Time frame: At inclusion
Brain functional connectivity networks analysis : extraction of resting state functional connectivity metrics from functional atlas or by voxel
Time frame: At 1 month follow-up
Cerebral morphometric extraction (3DT1): automatic segmentation
Time frame: At inclusion
Cerebral morphometric extraction (3DT1): automatic segmentation
Time frame: At 1 month follow-up
Cerebral morphometric extraction (3DT1): automatic segmentation
Time frame: At inclusion
Cerebral morphometric extraction (3DT1): automatic segmentation
Time frame: At 1 month follow-up
Cerebral morphometric extraction (3DT1): automatic segmentation
Time frame: At inclusion
Cerebral morphometric extraction (3DT1): automatic segmentation
Time frame: At 1 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
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 samples, Hetero-questionnaires and auto-questionnaires and Magnetic Resonance Imaging (MRI) in people with Suicide and 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?
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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe COURTET, MD PhD (+33 4 67 33 85 81, p-courtet@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of blood S100B assayed in the 3 groups, a marker of cerebral and vascular lesions. (time frame: At inclusion). The study lists 2 primary outcomes in all. 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 29 Nov 2023.