DepressionIBISNCT04137458
Exploration of the Relationship Between Inflammation and Integrity of the Blood-Brain Barrier in Suicidal Behaviour
A study testing Biological analysis in people with 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
- Depression
- What is being tested?
- Biological analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2019to Jul 2022
- 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
Who may be able to join
- 18-55 years old
- Able to understand nature, aims, and methodology of the study
- Depending on the population :
- Current depressive episode (according to DSM-5 criteria) with a recent suicide attempt (within the 8 days before inclusion) and no more than 3 attempts in life
- Current depressive episode (according to DSM-5 criteria) without suicide attempt
- No psychiatric history (according to DSM-5 criteria)
Who cannot join
- Inflammatory diseases or intercurrent infections, or chronic diseases such as hepatitis C or B, HIV, Alzheimer's, cancer or autoimmune disease
- Current antibiotic or anti-inflammatory treatments
- Refusal to participate
- Lifetime Schizoaffective disorder or schizophrenia
- On protective measures (guardianship or trusteeship)
- Deprived of liberty subject (administrative decision)
Show all 10Show fewer
- In exclusion period for another protocol
- Not affiliated to a social security agency
- Unable to understand and/or answer a questionnaire
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital
Montpellier, 34295
Catherine Genty, MD, +33 4 67 99 61 45 75, c-genty@chu-montpellier.fr
About this study
Official title: Exploration of the the Relationship Between Inflammation and Integrity of the Blood-brain Barrier in Suicidal Behaviour
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 BBB which normally acts as a filter to ensure proper neuronal functioning in suicidal vs. non suicidal patients.
Read the detailed description
105 participants will be recruited :
- 35 depressed patients having attempted suicide (maximum 3 attempts in life)
- 35 depressed patients without history of suicide attempt (affective controls)
- 35 healhy controls with no lifetime psychiatric history.
Only one visit is planned. A clinical assessment (2 hours) will be performed to characterise pschopathology and suicidal characteristics. Blood and salivary samples will be obtained in order to measure inflammatory markers.
- Conditions
- Depression
- Being tested
- Biological analysis
- Keywords
- Psychiatry, Blood Brain Barrie, Suicide attempt, Inflammation
- Medical subject headings
- Depression, Suicide, Attempted, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological analysisBiological
Blood and salivary samples will be taken at inclusion and a psychiatric assessment will be carried out
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | The investigator will withdraw biological samples and a biological and DNA bank will also be realized Receives: Biological: Biological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood level of S100B
Blood level of S100B measured in 3 groups (i.e. suicide attempters, affective controls, healthy controls)
Measured: at inclusion
Secondary outcomes (12)
Determination of leukocyte signature associated with suicidal behavior and depression
Comparison of the number and percentage of leukocytes (lymphocytes, monocytes, neutrophils) in the blood between the 3 patients groups
Measured: at inclusion
Profile of peripheral inflammation of each group
Characterization of activation state of leukocytes of CD4 / CD8 (T cells), NK cells, CD14 / CD33 (monocytes / macrophages)
Measured: at inclusion
Identification of general peripheral inflammation
Between groups comparison of blood levels of CRP
Measured: at inclusion
Pro-inflammatory profile based on cytokins of each group
Serum pro-inflammatory interleukins (IL) -1b, IL2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-9, IL-10, IL-12, IL-13 , TGF-b, interferon IFN-g, TNF-a, TNF-b
Measured: at inclusion
Profile of salivary interleukins
Profile of salivary interleukins Il-6, Il-13 et Il-17 within and between groups
Measured: at inclusion
Serum levels of glial fibrillary actin protein (GFAP)
Between group comparison of serum levels (ng / ml) of glial fibrillary actin protein (GFAP)
Measured: at inclusion
Serum levels of specific neuronal enolase (NSE)
Between group comparison of serum levels (ng / ml) of specific neuronal enolase (NSE)
Measured: at inclusion
Serum levels of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)
Between group comparison of serum levels (ng / ml) of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)
Measured: at inclusion
Salivary levels of S100B protein
Between group comparison of salivary levels of S100B protein
Measured: at inclusion
Salivary levels of specific neuronal enolase (NSE)
Between group comparison of salivary levels of specific neuronal enolase (NSE) in the 3 groups
Measured: at inclusion
Salivary levels of GFAP
Between group comparison of salivary levels of GFAP in the 3 groups
Measured: at inclusion
In vitro fluorescence ratio Dapi / phalloidin
The fluorescence ratio Dapi / phalloidin in a culture of neurovascular cells in the presence of the serum of the subjects (in vitro) in the 3 groups
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start7 Nov 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Courtet, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137458
- Sponsor's protocol ID
- RECHMPL19_0227
- Other IDs
- 2019-A01277-50
- Acronym
- IBIS
- Status last verified
- Oct 2021
- First submitted
- 21 Oct 2019
- Last updated
- 25 Oct 2021
- 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 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the the Relationship Between Inflammation and Integrity of the Blood-brain Barrier in Suicidal Behaviour
- ClinicalTrials.gov ID
- NCT04137458
- Acronym / sponsor ID
- IBIS / RECHMPL19_0227
- Conditions
- Depression
- Keywords
- Psychiatry, Blood Brain Barrie, Suicide attempt, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 24 Oct 2019 (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 BBB which normally acts as a filter to ensure proper neuronal functioning in suicidal vs. non suicidal patients.
Detailed description
105 participants will be recruited :
- 35 depressed patients having attempted suicide (maximum 3 attempts in life)
- 35 depressed patients without history of suicide attempt (affective controls)
- 35 healhy controls with no lifetime psychiatric history.
Only one visit is planned. A clinical assessment (2 hours) will be performed to characterise pschopathology and suicidal characteristics. Blood and salivary samples will be obtained in order to measure inflammatory markers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Biological: Biological analysisThe investigator will withdraw biological samples and a biological and DNA bank will also be realized |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-55 years old
- Able to understand nature, aims, and methodology of the study
- Current depressive episode (according to DSM-5 criteria) with a recent suicide attempt (within the 8 days before inclusion) and no more than 3 attempts in life
- Current depressive episode (according to DSM-5 criteria) without suicide attempt
- No psychiatric history (according to DSM-5 criteria)
Key exclusion criteria (10 listed)
- Inflammatory diseases or intercurrent infections, or chronic diseases such as hepatitis C or B, HIV, Alzheimer's, cancer or autoimmune disease
- Current antibiotic or anti-inflammatory treatments
- Refusal to participate
- Lifetime Schizoaffective disorder or schizophrenia
- On protective measures (guardianship or trusteeship)
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 |
|---|---|---|
| Biological analysisBlood and salivary samples will be taken at inclusion and a psychiatric assessment will be carried out | Biological | Participants |
Primary outcome
Blood level of S100B
Time frame: at inclusion
Blood level of S100B measured in 3 groups (i.e. suicide attempters, affective controls, healthy controls)
12 secondary outcomes
Determination of leukocyte signature associated with suicidal behavior and depression
Time frame: at inclusion
Profile of peripheral inflammation of each group
Time frame: at inclusion
Identification of general peripheral inflammation
Time frame: at inclusion
Pro-inflammatory profile based on cytokins of each group
Time frame: at inclusion
Profile of salivary interleukins
Time frame: at inclusion
Serum levels of glial fibrillary actin protein (GFAP)
Time frame: at inclusion
Serum levels of specific neuronal enolase (NSE)
Time frame: at inclusion
Serum levels of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)
Time frame: at inclusion
Salivary levels of S100B protein
Time frame: at inclusion
Salivary levels of specific neuronal enolase (NSE)
Time frame: at inclusion
Salivary levels of GFAP
Time frame: at inclusion
In vitro fluorescence ratio Dapi / phalloidin
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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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.
Philippe Courtet, MD PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological analysis in people with 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Oct 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?
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?
Blood level of S100B (time frame: at 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 25 Oct 2021.