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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 : April 3, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Diagnostic Test: Cerebral neuroinflammation evaluation Not Applicable

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.

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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.
Primary Purpose: Diagnostic
Official Title: Cerebral Neuroinflammation During Major Depressive Episode: Multicentric Comparative Study.
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).


  3. 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).

  4. 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).



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Inclusion criteria for all groups:

    • 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 for all groups:

    • 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Antoine Yrondi, MD PhD 5 34 55 75 37 ext 33 yrondi.a@chu-toulouse.fr

Locations
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France
Hôpital de Psychiatrie Recruiting
Toulouse, Midi-Pyrénées, France, 31059
Contact: Antoine Yrondi, PhD    5 34 55 75 37 ext 33    yrondi.a@chu-toulouse.fr   
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    bruno.aouizerate@u-bordeaux.fr   
Principal Investigator: Bruno Aouizerate, PhD         
Sub-Investigator: Philippe Fernandez, PhD         
Sub-Investigator: Marie Meyer, PhD         
Sub-Investigator: Vincent Dousset, Pr         
CHRU Lapeyronie Recruiting
Montpellier, Occitanie, France, 34295
Contact: Fanny Molière, PhD    4 67 33 67 33 ext 33    moliere@chu-montpellier.fr   
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    wissam.elhage@univ-tours.fr   
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         
Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Antoine Yrondi, MD PhD University Hospital, Toulouse

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03314155     History of Changes
Other Study ID Numbers: RC31/16/8918
2017-001478-40 ( EudraCT Number )
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Depressive disorder
Treatment Resistant Depression
[18 F ] DPA- 714
PET
MRI
Inflammation

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms