Clinical Trials Directory

Trials / Completed

CompletedNCT02359513

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
51 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGAntidepressantsbulimic patients are treated during 3 months
DRUGPositron Emission Tomography (PET)PET scan using \[18F\]MPPF is performed before and after (3 months)antidepressant treatment

Timeline

Start date
2015-11-09
Primary completion
2021-11-12
Completion
2022-03-11
First posted
2015-02-10
Last updated
2022-11-30

Locations

4 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02359513. Inclusion in this directory is not an endorsement.