Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy
BICS
Title: Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy.
2 other identifiers
interventional
69
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Feb 2017
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2017
CompletedDecember 21, 2021
December 1, 2021
10 months
January 31, 2017
December 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
At V1 (the day of the MRI)
Level of N-Acetyl-Aspartate (NAA)
At V1 (the day of the MRI)
Level of Choline (Cho)
At V1 (the day of the MRI)
Level of Myo-inositol (Myo)
At V1 (the day of the MRI)
Level of Creatinine (Cr)
At V1 (the day of the MRI)
- +8 more secondary outcomes
Study Arms (1)
Participants
OTHERAll 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.
Interventions
Participants will have to do a MRI and biological samples.
Eligibility Criteria
You may qualify if:
- Having signed informed consent
- Able to understand nature, aims and methodology of the study
- Suicidal patient with suicide attempt :
- Persistent depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria, and evaluated by the Mini International Neuropsychiatric Interview (MINI)
- Hamilton Depression Scale \> 7
- Suicide attempt \< 1 week
- Suicidal patient without suicide attempt :
- Persistent depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria, and evaluated by the Mini International Neuropsychiatric Interview (MINI)
- Hamilton Depression Scale \> 7
- No history of suicide attempt
- Healthy volunteers :
- No psychiatric history
- No history of suicide attempt
You may not qualify if:
- 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)
- Deprived of liberty subject (judicial or administrative decision)
- Pregnant women or breastfeeding
- Contraindications to MRI scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montpellier Hospital University
Montpellier, 34295, France
Related Publications (1)
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.
PMID: 39874064DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric COPPOLA, MD
Montpellier Hospital University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 14, 2017
Study Start
February 1, 2017
Primary Completion
November 29, 2017
Study Completion
November 29, 2017
Last Updated
December 21, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share