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Completed

NCT Number: NCT03052855

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier Hospital University

Montpellier, 34295, France

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging (MRI) and biological samples

Other

Participants will have to do a MRI and biological samples.

Primary outcomes

  1. Glutamine (Glu) and Glutamate (Glx) levels

    Time frame: 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 outcomes

  1. Link between rate of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 and suicide attempt

    Time frame: At V1 (the day of the MRI)

    Comparison of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 between the 3 groups

  2. Level of N-Acetyl-Aspartate (NAA)

    Time frame: 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

  3. Level of Choline (Cho)

    Time frame: 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

  4. Level of Myo-inositol (Myo)

    Time frame: 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

  5. Level of Creatinine (Cr)

    Time frame: 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

  6. Link between level of suicidal intentionality assessed by the Columbia Suicide Severity Rating Scale (CSS-RS) and metabolites levels

    Time frame: At V1 (the day of the MRI)

    Relationship between level of suicidal intentionality and Glu/Glx levels between the 3 groups

  7. Link between level of depression assessed by the clinician with the Hamilton Rating Scale (HAMD) and metabolite levels

    Time frame: At V1 (the day of the MRI)

    Relationship between level of depression and Glu/Glx levels between the 3 groups

  8. Link between level of depression self assessed with the Beck Scale and metabolites levels

    Time frame: At V1 (the day of the MRI)

    Relationship between level of depression and Glu/Glx levels between the 3 groups

  9. Link between rate of Tumor necrosis factor alpha (TNF α) and suicide attempt

    Time frame: At V1 (the day of the MRI)

    Comparison of biomarkers inflammation (TNF α) between the 3 groups

  10. Link between rate of Tumor necrosis factor beta (TNFβ) and suicide attempt

    Time frame: At V1 (the day of the MRI)

    Comparison of biomarkers inflammation (TNFβ) between the 3 groups

  11. Link between rate of Interferon gamma (IFNγ) and suicide attempt

    Time frame: At V1 (the day of the MRI)

    Comparison of biomarkers inflammation (IFNγ) between the 3 groups

  12. Link between rate of C-Reactive Protein (CRP) and suicide attempt

    Time frame: At V1 (the day of the MRI)

    Comparison of biomarkers inflammation (CRP) between the 3 groups

  13. Link between rate of Interferon Gamma Inducing Factors (IGIF)and suicide attempt

    Time frame: At V1 (the day of the MRI)

    Comparison of biomarkers inflammation (IGIF) between the 3 groups

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: BICS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 14, 2017
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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