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NCT Number: NCT02359513

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 (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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Groupement Hospitalier Est - HCL, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antidepressants

Drug

bulimic patients are treated during 3 months

Other names: Fluoxetine

Positron Emission Tomography (PET)

Drug

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

Other names: PET scan

Primary outcomes

  1. Correlation between [18F]MPPF Binding Potential (BP) and efficacy of antidepressant treatment

    Time frame: 3 months

    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 outcomes

  1. Correlation between [18F]MPPF Binding Potential (BP) and psychometric scores

    Time frame: 3 months

    Correlation between change from the baseline in [18F]MPPF BP and change from the baseline in psychometric scores at 3 months

  2. Correlation between [18F]MPPF Binding Potential (BP) and initial severity

    Time frame: 3 months

    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. Change from baseline in [18F]MPPF Binding Potential (BP)

    Time frame: 3 months

    Comparison between [18F]MPPF Binding Potential (BP) before antidepressant treatment (day 0) and after antidepressant treatment (month 3)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Feb 10, 2015
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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