Cerebral Neuroinflammation During Major Depressive Episode

  • STATUS
    Recruiting
  • End date
    Jan 25, 2022
  • participants needed
    60
  • sponsor
    University Hospital, Toulouse
Updated on 25 January 2021
remission
blood tests
antidepressants
depressive episode
major depressive disorder

Summary

the investigators make the following assumptions: 1) neuroinflammation in MDD can be measured by the [18 F ] DPA- 714 ; 2) it is accompanied by anatomical and functional changes in the frontal subcortical loops, strongly involved in MDD ; 3) neuroinflammation in patients might be a biomarker related to resistance to treatment in patients with MDD. If this assumptions are validated, then this study will enable a better understanding of the neuroinflammatory processes. This breakthrough could have a long term therapeutic impact, helping to target more specifically antidepressant drugs with anti-inflammatory action and / or drugs targeting neuroinflammation.

Description

The most widespread pathophysiological hypothesis in major depressive disorder (MDD), is the hypothesis of monoamine deficit. The most used antidepressants in everyday clinical practice act by inhibiting the reuptake of monoamines. However, meta-analyzes evaluating the efficacy of antidepressants suggest that they are ineffective in 30 to 40% of patients. Inflammatory mechanisms might be related to the deficiency of monoamines, compromising the effectiveness of conventional antidepressants. Newly developed specific radiotracers allow the use of positron emission tomography (PET) imaging techniques to evaluate neuroinflammation. It has recently demonstrated the relevance of the [18F] DPA- 714 as a biomarker of neuroinflammation in humans in several neurological diseases.

Details
Condition mood disorder, Endogenous depression, Mood Disorders (Pediatric), Affective Disorders, Mood Disorders, depressive disorder, depressive disorders
Treatment Cerebral neuroinflammation evaluation
Clinical Study IdentifierNCT03314155
SponsorUniversity Hospital, Toulouse
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written agreement for participation
Able to understand instructions and information data
Inclusion criteria for the experimental group
Responding to MDD criteria (DSM-5)
MADRS score> 20
Antidepressant medication considered ineffective and before the introduction of a new treatment according to the recommendations (unchanged dosage for at least a week and plasma levels within the therapeutic range)
Inclusion criteria for the pathological control group
Having met MDD criteria (DSM-5)
In remission for 8 weeks according to the DSM-5
MADRS score <10
Treated with antidepressants (unchanged dosage for at least week)
Inclusion criteria for the control group
Without any neurological or psychiatric previous disorder
CRPus < 5mg/L

Exclusion Criteria

Patients without public insurance regime
Specific contraindication to the use of MRI (metallic material) or PET (specific allergy related to the ligand)
Pregnant and breastfeeding women
Persons deprived of liberty by judicial or administrative decision
People hospitalized without consent, or subject to legal protection
Persons unable to consent
Patients with a neurodegenerative disease, bipolar disease, chronic psychotic disorder, addictive disorder, Obsessive Compulsive Disorder, Post-Traumatic Stress disorder (PCL-S> ou =45), known system pathology
Patients with a history of stroke
Patients with an acute infectious disease
Patients with chronic inflammatory pathology
Patients treated with anti-inflammatory and/or immunosuppressive, and/or antipsychotics, and/or diazepam
Exclusion criteria for control group
No significant psychiatric or somatic history
No psychotropic treatment
Suicidal risk (C-SSRS)
Anxiety Disorders (MINI)
Clear my responses

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