An interventional study of Cerebral neuroinflammation evaluation in Depressive Disorder, sponsored by University Hospital, Toulouse. Status unknown at 4 sites in France. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Diagnostic
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.
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.
855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.
This study's planned enrollment of 60 is below the median of 88 across 689 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for all groups:
Inclusion criteria for the experimental group:
Inclusion criteria for the pathological control group :
Inclusion criteria for the control group :
Exclusion criteria for all groups:
Exclusion criteria for control group:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
Time frame: Day 7
distribution pattern of neuroinflammation in PET data across all groups
Across all groups (i.e. experimental group, pathological control group and control group).
Time frame: Day 7
patients with depressive symptoms and neuroinflammation (i.e. PET data).
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).
Time frame: Day 7
patients with neuroinflammation (i.e. PET analysis) and MRI parameters for functional and structural integrities.
Correlation across all groups (experimental group, pathological control group and control group).
Time frame: Day 7
patients with neuroinflammation (i.e. PET analysis) and biological markers of neuroinflammation (i.e. cytokines).
Correlation across all groups (experimental group, pathological control group and control group).
Time frame: Day 7
Plan to share: No
Started Dec 2018 (actual). Primary completion is estimated for Jan 2024, 61 months after the start.
Of 260 non-industry interventional studies with no phase under Depressive Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 46. This study's planned 61 months is above that.
Counting every sponsor, half of 274 studies reached it within 29 months; a quarter within 15 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse →