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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001478-40 | EudraCT Number |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral neuroinflammation evaluation | Experimental | The density of TSPO (which is an inflammation maker) is evaluated by the tracer's brain distribution volume ([18F] DPA-714). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral neuroinflammation evaluation | Diagnostic Test | Pet scan following an injection of the radiotracer ([18F]DPA-714), to evaluate the neuroinflammation. MRI to evaluate functional and structural integrities. Blood test to analyze various inflammation marker (IL-6, Tumor Necrosis Factor (TNF) alpha, CRPus, and TSPO). And psychological scales to assess the depressive symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| distribution pattern of neuroinflammation in Positron Emission Tomography (PET) data | 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). | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| distribution pattern of neuroinflammation in PET data across all groups | Across all groups (i.e. experimental group, pathological control group and control group). | Day 7 |
| patients with depressive symptoms and neuroinflammation (i.e. PET data). |
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Inclusion criteria for all groups:
Inclusion criteria for the experimental group:
Inclusion criteria for the pathological control group :
Inclusion criteria for the control group :
Exclusion criteria for all groups:
Exclusion criteria for control group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine Yrondi, MD PhD | Contact | 5 34 55 75 37 | 33 | yrondi.a@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine Yrondi, MD PhD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de Psychiatrie | Recruiting | Toulouse | Midi-Pyrénées | 31059 | France |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D061218 | Depressive Disorder, Treatment-Resistant |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Images' analysis will be done by an INSERM engineer without the knowledge of the group to which the subjects belong.
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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).
| Day 7 |
| patients with neuroinflammation (i.e. PET analysis) and MRI parameters for functional and structural integrities. | Correlation across all groups (experimental group, pathological control group and control group). | Day 7 |
| patients with neuroinflammation (i.e. PET analysis) and biological markers of neuroinflammation (i.e. cytokines). | Correlation across all groups (experimental group, pathological control group and control group). | Day 7 |
| CHU Bordeaux | Not yet recruiting | Bordeaux | New Aquitaine | 33076 | France |
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| CHRU Lapeyronie | Recruiting | Montpellier | Occitanie | 34295 | France |
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| Clinique Psychiatrique Universitaire CHRU Tours | Recruiting | Tours | Val-De-Loire | 37540 | France |
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| 25806550 | Background | Maes M, Noto C, Brietzke E. Omics-based depression and inflammation research. Braz J Psychiatry. 2015 Jan-Mar;37(1):1-2. doi: 10.1590/1516-4446-2015-3609. No abstract available. |
| 17283286 | Background | Hasler G, van der Veen JW, Tumonis T, Meyers N, Shen J, Drevets WC. Reduced prefrontal glutamate/glutamine and gamma-aminobutyric acid levels in major depression determined using proton magnetic resonance spectroscopy. Arch Gen Psychiatry. 2007 Feb;64(2):193-200. doi: 10.1001/archpsyc.64.2.193. |
| 21498461 | Background | Deschwanden A, Karolewicz B, Feyissa AM, Treyer V, Ametamey SM, Johayem A, Burger C, Auberson YP, Sovago J, Stockmeier CA, Buck A, Hasler G. Reduced metabotropic glutamate receptor 5 density in major depression determined by [(11)C]ABP688 PET and postmortem study. Am J Psychiatry. 2011 Jul;168(7):727-34. doi: 10.1176/appi.ajp.2011.09111607. Epub 2011 Apr 15. |
| 11775046 | Background | Entsuah AR, Huang H, Thase ME. Response and remission rates in different subpopulations with major depressive disorder administered venlafaxine, selective serotonin reuptake inhibitors, or placebo. J Clin Psychiatry. 2001 Nov;62(11):869-77. doi: 10.4088/jcp.v62n1106. |
| 14662552 | Background | Blumberg HP, Kaufman J, Martin A, Whiteman R, Zhang JH, Gore JC, Charney DS, Krystal JH, Peterson BS. Amygdala and hippocampal volumes in adolescents and adults with bipolar disorder. Arch Gen Psychiatry. 2003 Dec;60(12):1201-8. doi: 10.1001/archpsyc.60.12.1201. |
| 12459219 | Background | Stone VE, Baron-Cohen S, Calder A, Keane J, Young A. Acquired theory of mind impairments in individuals with bilateral amygdala lesions. Neuropsychologia. 2003;41(2):209-20. doi: 10.1016/s0028-3932(02)00151-3. |
| 30087626 | Derived | Yrondi A, Aouizerate B, El-Hage W, Moliere F, Thalamas C, Delcourt N, Sporer M, Taib S, Schmitt L, Arlicot N, Meligne D, Sommet A, Salabert AS, Guillaume S, Courtet P, Galtier F, Mariano-Goulart D, Champfleur NM, Bars EL, Desmidt T, Lemaire M, Camus V, Santiago-Ribeiro MJ, Cottier JP, Fernandez P, Meyer M, Dousset V, Doumy O, Delhaye D, Capuron L, Leboyer M, Haffen E, Peran P, Payoux P, Arbus C. Assessment of Translocator Protein Density, as Marker of Neuroinflammation, in Major Depressive Disorder: A Pilot, Multicenter, Comparative, Controlled, Brain PET Study (INFLADEP Study). Front Psychiatry. 2018 Jul 24;9:326. doi: 10.3389/fpsyt.2018.00326. eCollection 2018. |