Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000365-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Bulimia nervosa (BN) is a serious mental illness characterized by massive food crises followed by anxiety and compensatory behaviours (vomiting more often). Recent data show an increasing prevalence and a serious prognosis, due to excess mortality by suicide but also somatic complications.
Two types of treatments are validated : serotoninergic antidepressants (SSRI) and psychotherapy. Many clinical trials confirm the effectiveness of the SSRI. But many studies also emphasize the important proportion of non-responders to SSRI, few of them analyze the reasons for this non-answer.
To better understand the mode of action of SSRI, we should analyse the serotonergic activity in the central nervous system in bulimia. Recently, specific brain 5HT1A serotonin receptor ligands ([18F] MPPF or [11 C] WAY-100635), were used in positron emission tomography (PET) to characterize the serotonergic abnormalities of bulimic patients. The ligand [18F] MPPF has the feature to be sensitive to the level of endogenous serotonin.
A first pilot study using PET with [18F] MPPF realized between the University Hospital of Saint Etienne and Lyon CERMEP showed a diffuse increase of the binding potential of [18F] MPPF in bulimic patients, suggesting a decrease in serotonin activity.
The brain regions affected were angular gyrus, medial frontal cortex, left insula, cingulate gyrus and orbitofrontal gyrus. These areas are involved in major bulimic symptoms (impulse, taste, instinct, anxiety and satiety). However, we noticed an interindividual heterogeneity of cortical binding of [18F] MPPF.
In front of the heterogeneity in terms of efficacity of SSRI and brain serotoninergic activity, it seems necessary to continues investigations, to determine if there is a link between brain serotonin profile and responding to SSRI in bulimia nervosa.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| boulimic | Experimental | Analyse of serotoninergic brain activity (determined by positron emission tomography using [18F]MPPF) from bulimic patients treated with serotoninergic antidepressants during 3 months. The serotoninergic brain activity is measured before adnd after the serotoninergic antidepressant treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antidepressants | Drug | bulimic patients are treated during 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between [18F]MPPF Binding Potential (BP) and efficacy of antidepressant treatment | Correlation between efficacy of antidepressant treatment quantified by change from the baseline in number of bulimic crises and the change from the baseline in [18F]MPPF BP at 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between [18F]MPPF Binding Potential (BP) and psychometric scores | Correlation between change from the baseline in [18F]MPPF BP and change from the baseline in psychometric scores at 3 months | 3 months |
| Correlation between [18F]MPPF Binding Potential (BP) and initial severity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bogdan GALUSCA, MD | CHU SAINT-ETIENNNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement Hospitalier Est - HCL | Bron | 69678 | France | |||
| CHU de Clermont-Ferrand |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Positron Emission Tomography (PET) | Drug | PET scan using [18F]MPPF is performed before and after (3 months)antidepressant treatment |
|
|
Correlation between [18F]MPPF Binding Potential (BP) at 3 months and initial (month 0) disease severity quantified by numbers bulimic crises over last 2 weeks before the initial evaluation and psychometric scores at initial evaluation (day 0) |
| 3 months |
| Change from baseline in [18F]MPPF Binding Potential (BP) | Comparison between [18F]MPPF Binding Potential (BP) before antidepressant treatment (day 0) and after antidepressant treatment (month 3) | 3 months |
| Clermont-Ferrand |
| France |
| CHU Grenoble | Grenoble | 38043 | France |
| Chu Saint-Etienne | Saint-Etienne | 42055 | France |
| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| D005473 | Fluoxetine |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided