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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000906-10 | EudraCT Number |
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The sponsor received the following instruction from the ANSM : "The sponsor shall conduct toxicity studies in accordance with the applicable guidelines, in particular " ICH guideline M3 (R2) on non-clinical safety studies for the conduct of human cli
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Serotoninergic activity in brain structures involved in food control and avoidance, such as the basal ganglia, is poorly understood in Anorexia Nervosa.
A simultaneous positron emission tomography (PET)- functional magnetic resonance imaging (fMRI) approach and testing of food preferences and choices will provide further insight into the link between potential abnormalities in serotoninergic transmission and the specific food restriction disorder for Anorexia Nervosa. These Data can pave the way for new therapeutic avenues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anorexia Nervosa patients | Experimental | 30 patients with anorexia nervosa = 15 with moderate to high anxiety (STAI YB anxiety (STAI YB > 51) and 15 with low anxiety (STAI YB<51). A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2. |
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| Controls | Placebo Comparator | 15 healthy volunteers (control group) and a low level of anxiety trait (< 51) A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET imaging using [11C]DASB radioligand. | Other | Subjects will be asked to complete a food choice task in PET/MRI. During the task, PET and MRI scans will be acquired simultaneously. This will allow us to see in real time during food choices the brain activations of the subjects. For imaging we will inject the DASB tracer intravenously. This radio ligand is a tracer that allows us to see the cerebral serotoninergic transmission by positron emission tomography. |
| Measure | Description | Time Frame |
|---|---|---|
| difference between the two groups of the study for serotonin binding potential | The difference in serotonin binding potential is measured by PET scan of the brain networks between anorexic and control subjects. | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state | serotonin binding potential is measured with [11C]DASB PET. abnormalities in brain activity is measured on fMRI. correlation between abnormalities in serotonin binding potential and abnormalities in brain activity is quantified by change in the resting state | Day 2 |
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Common Criteria for inclusion :
Inclusion Criteria: Patients with restrictive anorexia nervosa (30 subjects).
Inclusion criteria - Female control subjects (15 subjects)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bogdan GALUSCA, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Pathophysiological comparative study
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| Eye Tracker | Behavioral | The second technique used is the eye tracker that will allow us to analyze food avoidance behaviors through the eyes. With a "TOBII" eye tracker we wil be able to follow the gaze of the subjects during the food preference task. It is a non-invasive approach. |
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| correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks. | serotonin binding potential is measured with [11C]DASB PET. abnormalities in brain activity is measured on fMRI. correlation between abnormalities in serotonin binding potential and abnormalities in brain activity is quantified by change during the food choice tasks. | Day 2 |
| correlation between anxiety profile and brain activity | brain activity is measured on fMRI and anxiety is measured by the score STAI YB. STAI YB > 51 = Moderate to high anxiety STAI YB<51 = Low anxiety | Day 2 |