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Cerebral neuroinflammation during major depressive episode: multicentric comparative study (InflaDep)
EU CTIS ID: 2024-518405-18-00
What this study is testing
The primary outcome is to compare TEP data (i.e. distribution pattern of neuroinflammation) 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).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female / age between 18 and 60 years
- for the pathological control group : Treated with antidepressants (unchanged dosage for at least week)
- for the control group : Without any neurological or psychiatric previous disorder
- for the control group : CRPus < 5mg/L
- Written agreement for participation
- Able to understand instructions and information data
You likely can't join if
- 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
See the full eligibility criteria
- Male or female / age between 18 and 60 years
- for the pathological control group : Treated with antidepressants (unchanged dosage for at least week)
- for the control group : Without any neurological or psychiatric previous disorder
- for the control group : CRPus < 5mg/L
- Written agreement for participation
- Able to understand instructions and information data
- for the experimental group: Responding to MDD criteria (DSM-5)
- for the experimental group: MADRS score> 20
- for the experimental group: Antidepressant medication considered ineffective and before the introduction of a new treatment according to the recommendations (unchanged dosage for at least 2 week and plasma levels above the lower end of the therapeutic range done after one week more with unchanged dosage).
- for the pathological control group : Having met MDD criteria (DSM-5)
- for the pathological control group : In remission for 8 weeks according to the DSM-5
- for the pathological control group : MADRS score <10
- 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, known system pathology
- Patients with a history of stroke
- Patients with an acute infectious disease
- Persons with a phenotype of low affinity to the TSPO tracer
- Patients with chronic inflammatory pathology.
- Patients treated with anti-inflammatory and/or immunosuppressive, and/or antipsychotics, and/or benzodiazepine
- Diabetics
- History of documented head trauma
- for control group: No significant psychiatric or somatic history.
- for control group: No psychotropic treatment
- for control group: Suicidal risk (C-SSRS)
- for control group: Anxiety Disorders (MINI)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.