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

Bulimia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359513
• Other study ID #: 1408170
• Secondary ID: 2015-000365-31
• Status: Completed
• Phase: Phase 4
• Start date: November 9, 2015
• Est. completion date: March 11, 2022

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 11, 2022
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ?-HCG test before the exam

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa

Intervention

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

Locations

Country	Name	City	State
France	Groupement Hospitalier Est - HCL	Bron
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CHU Grenoble	Grenoble
France	Chu Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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)	3 months
Secondary	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