Cerebral Neuroinflammation During Major Depressive Episode (InflaDep)
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|ClinicalTrials.gov Identifier: NCT03314155|
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : July 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder||Diagnostic Test: Cerebral neuroinflammation evaluation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Images' analysis will be done by an INSERM engineer without the knowledge of the group to which the subjects belong.|
|Official Title:||Cerebral Neuroinflammation During Major Depressive Episode: Multicentric Comparative Study.|
|Actual Study Start Date :||December 7, 2018|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: Cerebral neuroinflammation evaluation
The density of TSPO (which is an inflammation maker) is evaluated by the tracer's brain distribution volume ([18F] DPA-714).
Diagnostic Test: Cerebral neuroinflammation evaluation
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.
- distribution pattern of neuroinflammation in Positron Emission Tomography (PET) data [ Time Frame: 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).
- distribution pattern of neuroinflammation in PET data across all groups [ Time Frame: Day 7 ]Across all groups (i.e. experimental group, pathological control group and control group).
- patients with depressive symptoms and neuroinflammation (i.e. PET data). [ Time Frame: 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).
- patients with neuroinflammation (i.e. PET analysis) and MRI parameters for functional and structural integrities. [ Time Frame: 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). [ Time Frame: Day 7 ]Correlation across all groups (experimental group, pathological control group and control group).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314155
|Contact: Antoine Yrondi, MD PhD||5 34 55 75 37 ext firstname.lastname@example.org|
|Hôpital de Psychiatrie||Recruiting|
|Toulouse, Midi-Pyrénées, France, 31059|
|Contact: Antoine Yrondi, PhD 5 34 55 75 37 ext 33 email@example.com|
|Principal Investigator: Antoine Yrondi, MD PhD|
|Sub-Investigator: Christophe Arbus, MD|
|Sub-Investigator: Marie Sporer, PhD|
|Sub-Investigator: Laurent Schmitt, MD|
|Sub-Investigator: Claire Thalamas, MD|
|Sub-Investigator: Fabienne Calvas, MD|
|Sub-Investigator: Monique Galitski, MD|
|Sub-Investigator: Pierre Payoux, MD|
|CHU Bordeaux||Not yet recruiting|
|Bordeaux, Nouvelle Aquitaine, France, 33076|
|Contact: Bruno Aouizerate, PhD 5 56 56 17 98 ext 33 firstname.lastname@example.org|
|Principal Investigator: Bruno Aouizerate, PhD|
|Sub-Investigator: Philippe Fernandez, PhD|
|Sub-Investigator: Marie Meyer, PhD|
|Sub-Investigator: Vincent Dousset, Pr|
|Montpellier, Occitanie, France, 34295|
|Contact: Fanny Molière, PhD 4 67 33 67 33 ext 33 email@example.com|
|Principal Investigator: Fanny Molière, PhD|
|Sub-Investigator: Sébastien Guillaume, PhD|
|Sub-Investigator: Philippe Courtet, PhD|
|Sub-Investigator: Florence Galtier, PhD|
|Sub-Investigator: Denis Mariano-Goulard, Pr|
|Sub-Investigator: Nicolas Menjot De Champfleur, PhD|
|Clinique Psychiatrique Universitaire CHRU Tours||Recruiting|
|Tours, Val-De-Loire, France, 37540|
|Contact: Wissam El-Hage, PhD 2 47 47 80 43 ext 33 firstname.lastname@example.org|
|Principal Investigator: Wissam El-Hage, PhD|
|Sub-Investigator: Vincent Camus, Pr|
|Sub-Investigator: Valérie Gissot, PhD|
|Sub-Investigator: Thomas Desmidt, PhD|
|Sub-Investigator: Mathieu Lemaire, PhD|
|Sub-Investigator: Maria-Joao Santiago-Ribeiro, PhD|
|Sub-Investigator: Jean-Philippe Cottier, PhD|
|Principal Investigator:||Antoine Yrondi, MD PhD||University Hospital, Toulouse|