A Phase 4 interventional study of Antidepressants and Positron Emission Tomography (PET) in Bulimia Nervosa, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 4 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 4, Interventional, and Treatment
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.
319 studies on the registry are indexed under Bulimia; 53 are open to participants now.
This study's enrollment of 51 is below the median of 61 across 249 interventional studies indexed under Bulimia.
Browse Bulimia studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
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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.
Drug: Antidepressants · Drug: Positron Emission Tomography (PET)
bulimic patients are treated during 3 months
Also known as: Fluoxetine
PET scan using \[18F\]MPPF is performed before and after (3 months)antidepressant treatment
Also known as: PET scan
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
Time frame: 3 months
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
Time frame: 3 months
Correlation between [18F]MPPF Binding Potential (BP) and initial severity
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)
Time frame: 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)
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne