DepressionBICSNCT03052855
Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy
A study testing Magnetic Resonance Imaging (MRI) and biological samples in people with Depression, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000 suicide attempts every year. SB management is therefore a major public health issue. Evidence associated dysregulation of the serotonergic system and the hypothalamic-pituitary-adrenal axis to vulnerability to SB. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Magnetic Resonance Imaging (MRI) and biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 29 Nov 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Actual somatic, neurological or inflammatory pathology (C-Reactive Protein > 10mg/L)
- Traumatic brain injury with loss of consciousness
- Antibiotic treatment or anti-inflammatory treatment
- Actual toxic abuse according to DSM-V (except tobacco and alcohol)
- Actual or passed history of psychotic disorder
- Patient on protective measures (guardianship or trusteeship)
Show all 9Show fewer
- Deprived of liberty subject (judicial or administrative decision)
- Pregnant women or breastfeeding
- Contraindications to MRI scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title: Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy.
Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000 suicide attempts every year. SB management is therefore a major public health issue.
Evidence associated dysregulation of the serotonergic system and the hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity. There is a need to better understand the physiopathology and develop diagnostic and therapeutic tools in SB.
Read more
The investigators hypothesize that increased peripheral biomarkers of inflammation would correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA, especially in suicidal patients.
Our aim is to compare rates of cerebral metabolites, in particular the complex glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with and without suicidal attempt.
Read the detailed description
69 patients : 23 with suicidal thoughts and attempt, 23 with suicidal thoughts without attempt and 23 healthy volunteers.
2 visits :
- Inclusion visit (V0) : (Day 1)
- Clinical interview : self and hetero assessment questionnaire
- Visit V1 (as soon as possible, day 1 if available) :
- MRI (spectroscopy)
- Conditions
- Depression
- Being tested
- Magnetic Resonance Imaging (MRI) and biological samples
- Keywords
- Psychiatry, Suicidal behaviour, Cerebral metabolites, MRI, Inflammatory markers
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI) and biological samplesOther
Participants will have to do a MRI and biological samples.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | All the participants of the 3 groups (depressed patients with suicide attempt, depressed patients without suicide attempt, healthy volunteers) will have to realize a MRI and biological samples. Receives: Other: Magnetic Resonance Imaging (MRI) and biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutamine (Glu) and Glutamate (Glx) levels
Levels of Glu/Glx in the anterior cingulate cortex and the orbitofrontal cortex between the depressed patients with and without suicide attempt
Measured: At V1 (the day of the MRI)
Secondary outcomes (13)
Link between rate of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 and suicide attempt
Comparison of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 between the 3 groups
Measured: At V1 (the day of the MRI)
Level of N-Acetyl-Aspartate (NAA)
Comparison of levels of NAA in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups
Measured: At V1 (the day of the MRI)
Level of Choline (Cho)
Comparison of levels of Cho in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups
Measured: At V1 (the day of the MRI)
Level of Myo-inositol (Myo)
Comparison of levels of Myo in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups
Measured: At V1 (the day of the MRI)
Level of Creatinine (Cr)
Comparison of levels of Creatinine (Cr) in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups
Measured: At V1 (the day of the MRI)
Link between level of suicidal intentionality assessed by the Columbia Suicide Severity Rating Scale (CSS-RS) and metabolites levels
Relationship between level of suicidal intentionality and Glu/Glx levels between the 3 groups
Measured: At V1 (the day of the MRI)
Link between level of depression assessed by the clinician with the Hamilton Rating Scale (HAMD) and metabolite levels
Relationship between level of depression and Glu/Glx levels between the 3 groups
Measured: At V1 (the day of the MRI)
Link between level of depression self assessed with the Beck Scale and metabolites levels
Relationship between level of depression and Glu/Glx levels between the 3 groups
Measured: At V1 (the day of the MRI)
Link between rate of Tumor necrosis factor alpha (TNF α) and suicide attempt
Comparison of biomarkers inflammation (TNF α) between the 3 groups
Measured: At V1 (the day of the MRI)
Link between rate of Tumor necrosis factor beta (TNFβ) and suicide attempt
Comparison of biomarkers inflammation (TNFβ) between the 3 groups
Measured: At V1 (the day of the MRI)
Link between rate of Interferon gamma (IFNγ) and suicide attempt
Comparison of biomarkers inflammation (IFNγ) between the 3 groups
Measured: At V1 (the day of the MRI)
Link between rate of C-Reactive Protein (CRP) and suicide attempt
Comparison of biomarkers inflammation (CRP) between the 3 groups
Measured: At V1 (the day of the MRI)
Link between rate of Interferon Gamma Inducing Factors (IGIF)and suicide attempt
Comparison of biomarkers inflammation (IGIF) between the 3 groups
Measured: At V1 (the day of the MRI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Feb 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric COPPOLA, MD, Principal investigator, Montpellier Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052855
- Sponsor's protocol ID
- UF9741
- Other IDs
- 2016-A01267-44
- Acronym
- BICS
- Status last verified
- Dec 2021
- First submitted
- 31 Jan 2017
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olie E, Clain G, Malestroit M, Fiedos D, Cognasse F, Deverdun J, Bars EL, Courtet P. Association of Suicidal Status, Inflammation Markers, and Resting-State Functional Activity and Connectivity in Patients With Major Depressive Disorder. J Clin Psychiatry. 2024 Jun 26;85(3):23m15148. doi: 10.4088/JCP.23m15148.
PubMed 39874064
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy.
- ClinicalTrials.gov ID
- NCT03052855
- Acronym / sponsor ID
- BICS / UF9741
- Conditions
- Depression
- Keywords
- Psychiatry, Suicidal behaviour, Cerebral metabolites, MRI, Inflammatory markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 14 Feb 2017 (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.
Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000 suicide attempts every year. SB management is therefore a major public health issue.
Evidence associated dysregulation of the serotonergic system and the hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity. There is a need to better understand the physiopathology and develop diagnostic and therapeutic tools in SB.
The investigators hypothesize that increased peripheral biomarkers of inflammation would correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA, especially in suicidal patients.
Our aim is to compare rates of cerebral metabolites, in particular the complex glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with and without suicidal attempt.
Detailed description
69 patients : 23 with suicidal thoughts and attempt, 23 with suicidal thoughts without attempt and 23 healthy volunteers.
2 visits :
- Inclusion visit (V0) : (Day 1)
- Clinical interview : self and hetero assessment questionnaire
- Visit V1 (as soon as possible, day 1 if available) :
- MRI (spectroscopy)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Other: Magnetic Resonance Imaging (MRI) and biological samplesAll the participants of the 3 groups (depressed patients with suicide attempt, depressed patients without suicide attempt, healthy volunteers) will have to realize a MRI and biological samples. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Actual somatic, neurological or inflammatory pathology (C-Reactive Protein > 10mg/L)
- Traumatic brain injury with loss of consciousness
- Antibiotic treatment or anti-inflammatory treatment
- Actual toxic abuse according to DSM-V (except tobacco and alcohol)
- Actual or passed history of psychotic disorder
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI) and biological samplesParticipants will have to do a MRI and biological samples. | Other | Participants |
Primary outcome
Glutamine (Glu) and Glutamate (Glx) levels
Time frame: At V1 (the day of the MRI)
Levels of Glu/Glx in the anterior cingulate cortex and the orbitofrontal cortex between the depressed patients with and without suicide attempt
13 secondary outcomes
Link between rate of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 and suicide attempt
Time frame: At V1 (the day of the MRI)
Level of N-Acetyl-Aspartate (NAA)
Time frame: At V1 (the day of the MRI)
Level of Choline (Cho)
Time frame: At V1 (the day of the MRI)
Level of Myo-inositol (Myo)
Time frame: At V1 (the day of the MRI)
Level of Creatinine (Cr)
Time frame: At V1 (the day of the MRI)
Link between level of suicidal intentionality assessed by the Columbia Suicide Severity Rating Scale (CSS-RS) and metabolites levels
Time frame: At V1 (the day of the MRI)
Link between level of depression assessed by the clinician with the Hamilton Rating Scale (HAMD) and metabolite levels
Time frame: At V1 (the day of the MRI)
Link between level of depression self assessed with the Beck Scale and metabolites levels
Time frame: At V1 (the day of the MRI)
Link between rate of Tumor necrosis factor alpha (TNF α) and suicide attempt
Time frame: At V1 (the day of the MRI)
Link between rate of Tumor necrosis factor beta (TNFβ) and suicide attempt
Time frame: At V1 (the day of the MRI)
Link between rate of Interferon gamma (IFNγ) and suicide attempt
Time frame: At V1 (the day of the MRI)
Link between rate of C-Reactive Protein (CRP) and suicide attempt
Time frame: At V1 (the day of the MRI)
Link between rate of Interferon Gamma Inducing Factors (IGIF)and suicide attempt
Time frame: At V1 (the day of the MRI)
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 21 Dec 2021.
- Derived from this study: PubMed 39874064Olie E, Clain G, Malestroit M, Fiedos D, Cognasse F, Deverdun J, Bars EL, Courtet P. Association of Suicidal Status, Inflammation Markers, and Resting-State Functional Activity and Connectivity in Patients With Major Depressive Disorder. J Clin Psychiatry. 2024 Jun 26;85(3):23m15148. doi: 10.4088/JCP.23m15148.
- 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.
Frédéric COPPOLA, MD principal investigator
Montpellier Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) and biological samples 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 0 inclusion and 9 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 21 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?
Glutamine (Glu) and Glutamate (Glx) levels (time frame: At V1 (the day of the MRI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052855, which also lists 1 linked publication.
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 21 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.