Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy

Not Applicable

Completed

• Conditions: Depression
• Interventions: Other: Magnetic Resonance Imaging (MRI) and biological samples

• Registration Number: NCT03052855
• Lead Sponsor: University Hospital, Montpellier

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.

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)

o Clinical interview : self and hetero assessment questionnaire

* Visit V1 (as soon as possible, day 1 if available) :

* MRI (spectroscopy)

Study Timeline

• Study First Submitted: 2017-01-31
• Study Start: 2017-02-01
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Primary Completion: 2017-11-29
• Study Completion: 2017-11-29
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Magnetic Resonance Imaging (MRI) and biological samples	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.

Primary Outcome Measures

Name	Time	Method
Glutamine (Glu) and Glutamate (Glx) levels	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

Secondary Outcome Measures

Name	Time	Method
Link between rate of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 and suicide attempt	At V1 (the day of the MRI)	Comparison of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 between the 3 groups
Level of N-Acetyl-Aspartate (NAA)	At V1 (the day of the MRI)	Comparison of levels of NAA in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups
Level of Choline (Cho)	At V1 (the day of the MRI)	Comparison of levels of Cho in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups
Level of Myo-inositol (Myo)	At V1 (the day of the MRI)	Comparison of levels of Myo in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups
Level of Creatinine (Cr)	At V1 (the day of the MRI)	Comparison of levels of Creatinine (Cr) in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups
Link between level of depression self assessed with the Beck Scale and metabolites levels	At V1 (the day of the MRI)	Relationship between level of depression and Glu/Glx levels between the 3 groups
Link between level of suicidal intentionality assessed by the Columbia Suicide Severity Rating Scale (CSS-RS) and metabolites levels	At V1 (the day of the MRI)	Relationship between level of suicidal intentionality and Glu/Glx levels between the 3 groups
Link between level of depression assessed by the clinician with the Hamilton Rating Scale (HAMD) and metabolite levels	At V1 (the day of the MRI)	Relationship between level of depression and Glu/Glx levels between the 3 groups
Link between rate of Tumor necrosis factor alpha (TNF α) and suicide attempt	At V1 (the day of the MRI)	Comparison of biomarkers inflammation (TNF α) between the 3 groups
Link between rate of Tumor necrosis factor beta (TNFβ) and suicide attempt	At V1 (the day of the MRI)	Comparison of biomarkers inflammation (TNFβ) between the 3 groups
Link between rate of Interferon gamma (IFNγ) and suicide attempt	At V1 (the day of the MRI)	Comparison of biomarkers inflammation (IFNγ) between the 3 groups
Link between rate of C-Reactive Protein (CRP) and suicide attempt	At V1 (the day of the MRI)	Comparison of biomarkers inflammation (CRP) between the 3 groups
Link between rate of Interferon Gamma Inducing Factors (IGIF)and suicide attempt	At V1 (the day of the MRI)	Comparison of biomarkers inflammation (IGIF) between the 3 groups

Trial Locations

Locations (1)

Montpellier Hospital University; 🇫🇷 Montpellier, France