NCT03052855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

10 months

First QC Date

January 31, 2017

Last Update Submit

December 20, 2021

Conditions

Keywords

PsychiatrySuicidal behaviourCerebral metabolitesMRIInflammatory markers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

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

    At V1 (the day of the MRI)

  • Level of N-Acetyl-Aspartate (NAA)

    At V1 (the day of the MRI)

  • Level of Choline (Cho)

    At V1 (the day of the MRI)

  • Level of Myo-inositol (Myo)

    At V1 (the day of the MRI)

  • Level of Creatinine (Cr)

    At V1 (the day of the MRI)

  • +8 more secondary outcomes

Study Arms (1)

Participants

OTHER

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

Interventions

Participants will have to do a MRI and biological samples.

Participants

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier Hospital University

Montpellier, 34295, France

Location

Related Publications (1)

  • Olie E, Clain G, Malestroit M, Fiedos D, Cognasse F, Deverdun J, Bars EL, Courtet P. Association of Suicidal Status, Inflammation Markers, and Resting-State Functional Activity and Connectivity in Patients With Major Depressive Disorder. J Clin Psychiatry. 2024 Jun 26;85(3):23m15148. doi: 10.4088/JCP.23m15148.

MeSH Terms

Conditions

Depression

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Frédéric COPPOLA, MD

    Montpellier Hospital University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 14, 2017

Study Start

February 1, 2017

Primary Completion

November 29, 2017

Study Completion

November 29, 2017

Last Updated

December 21, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations