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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Depression

Treatments

Other: Magnetic Resonance Imaging (MRI) and biological samples

Study type

Interventional

Funder types

Other

Identifiers

NCT03052855
UF9741
2016-A01267-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment

69 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

69 participants in 1 patient group

Participants
Other group
Description:
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.
Treatment:
Other: Magnetic Resonance Imaging (MRI) and biological samples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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