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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 co

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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)
  • 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)


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Saint Etienne

Dates:
Date Received: February 2, 2015
Date Started: November 9, 2015
Date Completion: March 2018
Last Updated: April 7, 2017
Last Verified: April 2017