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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT03052855

Collaborator

(none)

Enrollment

Location

Arm

9.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Other: Magnetic Resonance Imaging (MRI) and biological samples	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Nov 29, 2017

Actual Study Completion Date :

Nov 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Participants 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.	Other: Magnetic Resonance Imaging (MRI) and biological samples Participants will have to do a MRI and biological samples.

Arm

Intervention/Treatment

Other: Participants

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.

Other: Magnetic Resonance Imaging (MRI) and biological samples

Participants will have to do a MRI and biological samples.

Outcome Measures

Primary Outcome Measures

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

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 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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Non-specific inclusion criteria:

Having signed informed consent
Able to understand nature, aims and methodology of the study

Specific inclusion criteria :

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

Exclusion criteria:

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