Cerebral Neuroinflammation During Major Depressive Episode (InflaDep)

March 29, 2023 updated by: University Hospital, Toulouse

Cerebral Neuroinflammation During Major Depressive Episode: Multicentric Comparative Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Midi-Pyrénées
      • Toulouse, Midi-Pyrénées, France, 31059
        • Recruiting
        • Hôpital de Psychiatrie
        • Sub-Investigator:
          • Claire Thalamas, MD
        • Contact:
        • Principal Investigator:
          • Antoine Yrondi, MD PhD
        • Sub-Investigator:
          • Christophe ARBUS, MD
        • Sub-Investigator:
          • Marie Sporer, PhD
        • Sub-Investigator:
          • Laurent Schmitt, MD
        • Sub-Investigator:
          • Fabienne Calvas, MD
        • Sub-Investigator:
          • Monique Galitski, MD
        • Sub-Investigator:
          • Pierre Payoux, MD
    • Nouvelle Aquitaine
      • Bordeaux, Nouvelle Aquitaine, France, 33076
        • Not yet recruiting
        • CHU Bordeaux
        • Contact:
        • Principal Investigator:
          • Bruno Aouizerate, PhD
        • Sub-Investigator:
          • Philippe Fernandez, PhD
        • Sub-Investigator:
          • Marie Meyer, PhD
        • Sub-Investigator:
          • Vincent Dousset, Pr
    • Occitanie
      • Montpellier, Occitanie, France, 34295
        • Recruiting
        • CHRU Lapeyronie
        • Contact:
        • 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
    • Val-De-Loire
      • Tours, Val-De-Loire, France, 37540
        • Recruiting
        • Clinique Psychiatrique Universitaire CHRU Tours
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 7
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).
Day 7
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).
Day 7
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).
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Antoine Yrondi, MD PhD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2018

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/16/8918
  • 2017-001478-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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