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

Depression Clinical Trial

— BICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052855
• Other study ID #: UF9741
• Secondary ID: 2016-A01267-44
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: November 29, 2017

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Other:
• Magnetic Resonance Imaging (MRI) and biological samples
Participants will have to do a MRI and biological samples.

Locations

Country	Name	City	State
France	Montpellier Hospital University	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	At V1 (the day of the MRI)
Secondary	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	At V1 (the day of the MRI)
Secondary	Level of Choline (Cho)	Comparison of levels of Cho in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups	At V1 (the day of the MRI)
Secondary	Level of Myo-inositol (Myo)	Comparison of levels of Myo in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups	At V1 (the day of the MRI)
Secondary	Level of Creatinine (Cr)	Comparison of levels of Creatinine (Cr) in the anterior cingulate cortex and the orbito-frontal cortex between the 3 groups	At V1 (the day of the MRI)
Secondary	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	At V1 (the day of the MRI)
Secondary	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	At V1 (the day of the MRI)
Secondary	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	At V1 (the day of the MRI)
Secondary	Link between rate of Tumor necrosis factor alpha (TNF a) and suicide attempt	Comparison of biomarkers inflammation (TNF a) between the 3 groups	At V1 (the day of the MRI)
Secondary	Link between rate of Tumor necrosis factor beta (TNFß) and suicide attempt	Comparison of biomarkers inflammation (TNFß) between the 3 groups	At V1 (the day of the MRI)
Secondary	Link between rate of Interferon gamma (IFN?) and suicide attempt	Comparison of biomarkers inflammation (IFN?) between the 3 groups	At V1 (the day of the MRI)
Secondary	Link between rate of C-Reactive Protein (CRP) and suicide attempt	Comparison of biomarkers inflammation (CRP) between the 3 groups	At V1 (the day of the MRI)
Secondary	Link between rate of Interferon Gamma Inducing Factors (IGIF)and suicide attempt	Comparison of biomarkers inflammation (IGIF) between the 3 groups	At V1 (the day of the MRI)