Clinical trial NCT03052855: Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy
Official title: Title: Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Psychiatry
Suicidal behaviour
Cerebral metabolites
MRI
Inflammatory markers
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)

Eligibility criteria: 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

Primary outcomes:
measure: Glutamine (Glu) and Glutamate (Glx) levels
timeFrame: At V1 (the day of the MRI)
Secondary outcomes:
measure: Link between rate of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 and suicide attempt
timeFrame: At V1 (the day of the MRI)
measure: Level of N-Acetyl-Aspartate (NAA)
timeFrame: At V1 (the day of the MRI)
measure: Level of Choline (Cho)
timeFrame: At V1 (the day of the MRI)
measure: Level of Myo-inositol (Myo)
timeFrame: At V1 (the day of the MRI)
measure: Level of Creatinine (Cr)
timeFrame: At V1 (the day of the MRI)
measure: Link between level of suicidal intentionality assessed by the Columbia Suicide Severity Rating Scale (CSS-RS) and metabolites levels
timeFrame: At V1 (the day of the MRI)
measure: Link between level of depression assessed by the clinician with the Hamilton Rating Scale (HAMD) and metabolite levels
timeFrame: At V1 (the day of the MRI)
measure: Link between level of depression self assessed with the Beck Scale and metabolites levels
timeFrame: At V1 (the day of the MRI)
measure: Link between rate of Tumor necrosis factor alpha (TNF α) and suicide attempt
timeFrame: At V1 (the day of the MRI)
measure: Link between rate of Tumor necrosis factor beta (TNFβ) and suicide attempt
timeFrame: At V1 (the day of the MRI)
measure: Link between rate of Interferon gamma (IFNγ) and suicide attempt
timeFrame: At V1 (the day of the MRI)
measure: Link between rate of C-Reactive Protein (CRP) and suicide attempt
timeFrame: At V1 (the day of the MRI)
measure: Link between rate of Interferon Gamma Inducing Factors (IGIF)and suicide attempt
timeFrame: At V1 (the day of the MRI)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier Hospital University
Study officials:
affiliation: Montpellier Hospital University
name: Frédéric COPPOLA, MD
role: PRINCIPAL_INVESTIGATOR
References: