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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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