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

NCT ID: NCT02359513

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-09
• Study Completion Date: 2022-03-11

Brief 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.

Conditions

Bulimia Nervosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Antidepressants

Intervention Type: DRUG

bulimic patients are treated during 3 months

Positron Emission Tomography (PET)

Intervention Type: DRUG

PET scan using \[18F\]MPPF is performed before and after (3 months)antidepressant treatment

Interventions

Antidepressants

bulimic patients are treated during 3 months

Intervention Type: DRUG

Positron Emission Tomography (PET)

PET scan using \[18F\]MPPF is performed before and after (3 months)antidepressant treatment

Intervention Type: DRUG

Other Intervention Names

Fluoxetine; PET scan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bogdan GALUSCA, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNNE

Locations

Groupement Hospitalier Est - HCL

Bron, , France

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

CHU Grenoble

Grenoble, , France

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2015-000365-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1408170

Identifier Type: -

Identifier Source: org_study_id