Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF.

Overview

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.

Full Title of Study: “Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF – a Multicenter Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2022

Interventions

  • Drug: Antidepressants
    • bulimic patients are treated during 3 months
  • Drug: Positron Emission Tomography (PET)
    • PET scan using [18F]MPPF is performed before and after (3 months)antidepressant treatment

Arms, Groups and Cohorts

  • Experimental: boulimic
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Correlation between [18F]MPPF Binding Potential (BP) and efficacy of antidepressant treatment
    • Time Frame: 3 months
    • 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

Secondary Measures

  • Correlation between [18F]MPPF Binding Potential (BP) and psychometric scores
    • Time Frame: 3 months
    • Correlation between change from the baseline in [18F]MPPF BP and change from the baseline in psychometric scores at 3 months
  • Correlation between [18F]MPPF Binding Potential (BP) and initial severity
    • Time Frame: 3 months
    • 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)
  • Change from baseline in [18F]MPPF Binding Potential (BP)
    • Time Frame: 3 months
    • Comparison between [18F]MPPF Binding Potential (BP) before antidepressant treatment (day 0) and after antidepressant treatment (month 3)

Participating in This Clinical Trial

Inclusion Criteria

  • Patient affiliated or entitled to a social security scheme – Bulimic patients according to DSM-IV TR: minimum 2 bulimic crises (compulsive eating followed by compensatory behavior) / week for 3 weeks – Patients who signed informed consent to the study – BMI greater than or equal to 18.5 kg / m² Exclusion Criteria:

  • Against-indication to the SSRI or fluoxetine – SSRI consumption in the previous three months – Other addiction (except tobacco, for reasons of feasibility) – Diagnosis of binge eating disorder or EDNOS (DSM-IV-TR) – Patients with heart failure – Against-indication for PET and / or MRI: pacemaker, intracerebral clips, prosthesis made of ferromagnetic material or claustrophobia – Subjects with suspected pregnancy or in the second half of their menstrual cycle in the absence of oral contraceptives; positive Β-HCG test before the exam

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bogdan GALUSCA, MD, Principal Investigator, CHU SAINT-ETIENNNE
  • Overall Contact(s)
    • Bogdan GALUSCA, MD, (0)477127594, bogdan.galusca@chu-st-etienne.fr

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