Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF.
Primary Purpose
Bulimia Nervosa
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Antidepressants
Positron Emission Tomography (PET)
Sponsored by
About this trial
This is an interventional treatment trial for Bulimia Nervosa focused on measuring bulimia, serotoninergic brain activity, fluoxetine, serotoninergic antidepressant, brain serotonin profile, positon emission tomography
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
Sites / Locations
- Groupement Hospitalier Est - HCL
- CHU de Clermont-Ferrand
- CHU Grenoble
- Chu Saint-Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
boulimic
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
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)
Full Information
NCT ID
NCT02359513
First Posted
February 2, 2015
Last Updated
November 29, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT02359513
Brief Title
Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF.
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2015 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
March 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
bulimia, serotoninergic brain activity, fluoxetine, serotoninergic antidepressant, brain serotonin profile, positon emission tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
boulimic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Antidepressants
Other Intervention Name(s)
Fluoxetine
Intervention Description
bulimic patients are treated during 3 months
Intervention Type
Drug
Intervention Name(s)
Positron Emission Tomography (PET)
Other Intervention Name(s)
PET scan
Intervention Description
PET scan using [18F]MPPF is performed before and after (3 months)antidepressant treatment
Primary Outcome Measure Information:
Title
Correlation between [18F]MPPF Binding Potential (BP) and efficacy of antidepressant treatment
Description
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
Secondary Outcome Measure Information:
Title
Correlation between [18F]MPPF Binding Potential (BP) and psychometric scores
Description
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
Title
Correlation between [18F]MPPF Binding Potential (BP) and initial severity
Description
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
Title
Change from baseline in [18F]MPPF Binding Potential (BP)
Description
Comparison between [18F]MPPF Binding Potential (BP) before antidepressant treatment (day 0) and after antidepressant treatment (month 3)
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bogdan GALUSCA, MD
Organizational Affiliation
CHU SAINT-ETIENNNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupement Hospitalier Est - HCL
City
Bron
ZIP/Postal Code
69678
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Chu Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF.
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