Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF.
2 other identifiers
interventional
51
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2015
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 10, 2015
CompletedStudy Start
First participant enrolled
November 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2022
CompletedNovember 30, 2022
March 1, 2022
6 years
February 2, 2015
November 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Correlation between [18F]MPPF Binding Potential (BP) and psychometric scores
3 months
Correlation between [18F]MPPF Binding Potential (BP) and initial severity
3 months
Change from baseline in [18F]MPPF Binding Potential (BP)
3 months
Study Arms (1)
boulimic
EXPERIMENTALAnalyse 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.
Interventions
PET scan using \[18F\]MPPF is performed before and after (3 months)antidepressant treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Groupement Hospitalier Est - HCL
Bron, 69678, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU Grenoble
Grenoble, 38043, France
Chu Saint-Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bogdan GALUSCA, MD
CHU SAINT-ETIENNNE
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 10, 2015
Study Start
November 9, 2015
Primary Completion
November 12, 2021
Study Completion
March 11, 2022
Last Updated
November 30, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share