Cerebral Neuroinflammation During Major Depressive Episode
- Conditions
- Depressive Disorder
- Interventions
- Diagnostic Test: Cerebral neuroinflammation evaluation
- Registration Number
- NCT03314155
- Lead Sponsor
- University Hospital, Toulouse
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cerebral neuroinflammation evaluation Cerebral neuroinflammation evaluation The density of TSPO (which is an inflammation maker) is evaluated by the tracer's brain distribution volume (\[18F\] DPA-714).
- Primary Outcome Measures
Name Time Method distribution pattern of neuroinflammation in Positron Emission Tomography (PET) data Day 7 Assessed between patients with MDD (experimental group), patients who have had a MDD and being in remission for at least 8 weeks, still treated with antidepressants, matched in age and gender with the experimental group (pathological control group) and control subjects, matched in gender and age with both patients' groups (control group).
- Secondary Outcome Measures
Name Time Method patients with depressive symptoms and neuroinflammation (i.e. PET data). Day 7 Depressive symptoms are assessed by the Montgomery and Asberg Depression Scale (MADRS) and the Columbia-Suicide severity rating scale (CSSRS).
Correlation across all groups (experimental group, pathological control group and control group).distribution pattern of neuroinflammation in PET data across all groups Day 7 Across all groups (i.e. experimental group, pathological control group and control group).
patients with neuroinflammation (i.e. PET analysis) and MRI parameters for functional and structural integrities. Day 7 Correlation across all groups (experimental group, pathological control group and control group).
patients with neuroinflammation (i.e. PET analysis) and biological markers of neuroinflammation (i.e. cytokines). Day 7 Correlation across all groups (experimental group, pathological control group and control group).
Trial Locations
- Locations (4)
Hôpital de Psychiatrie
🇫🇷Toulouse, Midi-Pyrénées, France
CHU Bordeaux
🇫🇷Bordeaux, Nouvelle Aquitaine, France
CHRU Lapeyronie
🇫🇷Montpellier, Occitanie, France
Clinique Psychiatrique Universitaire CHRU Tours
🇫🇷Tours, Val-De-Loire, France