Status:
UNKNOWN
Inflammation and Blood Brain Barrier Integrity as Biomarkers of Suicidal Behavior
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Suicide
Depression
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in mi...
Detailed Description
150 participants will be enrolled, divided into 3 groups: * 50 Suicide attempters, i.e. currently depressed patients with a suicide attempt within the 8 last days (with a maximal lifetime number of 3...
Eligibility Criteria
Inclusion
- Common inclusion criteria:
- Aged between 18 and 55 years old,
- Affiliated to a French National Social Security System
- Able to understand the nature, purpose and methodology of the study
- Able to give written informed consent
- Specific inclusion criteria
- Suicide attempters:
- Subject with a main psychiatric diagnosis of current major depressive episode according to DSM-5 criteria (the existence of psychiatric comorbidities is not a non-inclusion criterion)
- Subject with a recent history of proven suicide attempt (within the 8 days before inclusion)
- Subject with a history of maximum 2 previous lifetime proven SA
- Affective controls:
- Subject with a main psychiatric diagnosis of current major depressive episode according to DSM-5 criteria (the existence of psychiatric comorbidities is not a non-inclusion criterion),
- Subject without any lifetime history suicidal behavior (proven, interrupted or aborted)
- Healthy controls:
- \- Subject who have no current or past personal history of psychiatric disorders according to DSM5 criteria.
- Non inclusion criteria
- History of psychotic disorders
- Diagnostic of illicit substance / alcohol use disorder within the last 6 months
- Current inflammation-related symptoms including fever and infectious or inflammatory disease
- Severe symptomatic or unstable medical condition (e.g., unstable endocrine or cardiovascular disease)
- Medical disorders affecting CNS function (e.g., history of severe head trauma, epilepsy, tumor)
- Current use of specific medications known to affect the immune system, such as corticosteroids, non-steroid anti-inflammatory drugs, aspirin and statins
- Contraindication to MRI or impossibility to assess, or doubt about a contraindication to the MRI: metallic artificial heart valve, pacemaker, cerebrovascular clips ferromagnetic materials, metallic foreign body that can be mobilized, in particular cerebral or intraocular, prosthesis ferromagnetic, impossibility of absolute immobility in supine position, claustrophobia.
- Vaccination in the last month
- Law protected or deprived of liberty subject
- Pregnant and breastfeeding women
- BMI \> 30 kg/m2
- Having reached 6000€ annual compensation for participating to clinical trials
- Being in exclusion period for another study
Exclusion
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06047613
Start Date
October 5 2023
End Date
October 1 2025
Last Update
November 29 2023
Active Locations (1)
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1
University hospital
Montpellier, France, 34295