SEVIALANO: Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT05155280

Collaborator

(none)

Enrollment

Location

Arms

19.7

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Serotoninergic activity in brain structures involved in food control and avoidance, such as the basal ganglia, is poorly understood in Anorexia Nervosa.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Other: PET imaging using [11C]DASB radioligand. Behavioral: Eye Tracker	N/A

Detailed Description

A simultaneous positron emission tomography (PET)- functional magnetic resonance imaging (fMRI) approach and testing of food preferences and choices will provide further insight into the link between potential abnormalities in serotoninergic transmission and the specific food restriction disorder for Anorexia Nervosa. These Data can pave the way for new therapeutic avenues.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Pathophysiological comparative studyPathophysiological comparative study

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa : Study of Gaze Control and Multimodal Brain Imaging

Actual Study Start Date :

Dec 10, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anorexia Nervosa patients 30 patients with anorexia nervosa = 15 with moderate to high anxiety (STAI YB anxiety (STAI YB > 51) and 15 with low anxiety (STAI YB<51). A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2.	Other: PET imaging using [11C]DASB radioligand. Subjects will be asked to complete a food choice task in PET/MRI. During the task, PET and MRI scans will be acquired simultaneously. This will allow us to see in real time during food choices the brain activations of the subjects. For imaging we will inject the DASB tracer intravenously. This radio ligand is a tracer that allows us to see the cerebral serotoninergic transmission by positron emission tomography. Behavioral: Eye Tracker The second technique used is the eye tracker that will allow us to analyze food avoidance behaviors through the eyes. With a "TOBII" eye tracker we wil be able to follow the gaze of the subjects during the food preference task. It is a non-invasive approach.
Placebo Comparator: Controls 15 healthy volunteers (control group) and a low level of anxiety trait (< 51) A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2.	Other: PET imaging using [11C]DASB radioligand. Subjects will be asked to complete a food choice task in PET/MRI. During the task, PET and MRI scans will be acquired simultaneously. This will allow us to see in real time during food choices the brain activations of the subjects. For imaging we will inject the DASB tracer intravenously. This radio ligand is a tracer that allows us to see the cerebral serotoninergic transmission by positron emission tomography. Behavioral: Eye Tracker The second technique used is the eye tracker that will allow us to analyze food avoidance behaviors through the eyes. With a "TOBII" eye tracker we wil be able to follow the gaze of the subjects during the food preference task. It is a non-invasive approach.

Arm

Intervention/Treatment

Experimental: Anorexia Nervosa patients

30 patients with anorexia nervosa = 15 with moderate to high anxiety (STAI YB anxiety (STAI YB > 51) and 15 with low anxiety (STAI YB<51). A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2.

Other: PET imaging using [11C]DASB radioligand.

Subjects will be asked to complete a food choice task in PET/MRI. During the task, PET and MRI scans will be acquired simultaneously. This will allow us to see in real time during food choices the brain activations of the subjects. For imaging we will inject the DASB tracer intravenously. This radio ligand is a tracer that allows us to see the cerebral serotoninergic transmission by positron emission tomography.

Behavioral: Eye Tracker

The second technique used is the eye tracker that will allow us to analyze food avoidance behaviors through the eyes. With a "TOBII" eye tracker we wil be able to follow the gaze of the subjects during the food preference task. It is a non-invasive approach.

Placebo Comparator: Controls

15 healthy volunteers (control group) and a low level of anxiety trait (< 51) A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2.

Other: PET imaging using [11C]DASB radioligand.

Behavioral: Eye Tracker

Outcome Measures

Primary Outcome Measures

difference between the two groups of the study for serotonin binding potential [Day 2]
The difference in serotonin binding potential is measured by PET scan of the brain networks between anorexic and control subjects.

Secondary Outcome Measures

correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state [Day 2]
serotonin binding potential is measured with [11C]DASB PET. abnormalities in brain activity is measured on fMRI. correlation between abnormalities in serotonin binding potential and abnormalities in brain activity is quantified by change in the resting state
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks. [Day 2]
serotonin binding potential is measured with [11C]DASB PET. abnormalities in brain activity is measured on fMRI. correlation between abnormalities in serotonin binding potential and abnormalities in brain activity is quantified by change during the food choice tasks.
correlation between anxiety profile and brain activity [Day 2]
brain activity is measured on fMRI and anxiety is measured by the score STAI YB. STAI YB > 51 = Moderate to high anxiety STAI YB<51 = Low anxiety

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Common Criteria for inclusion :

Signature of written consent
Subject affiliated or entitled to a social security scheme

Inclusion Criteria: Patients with restrictive anorexia nervosa (30 subjects).

Anorexia nervosa common features : fear of weight gain, dysmorphophobia, BMI < 17.5 kg/ m², amenorrhea
Absence of food compulsions and purges
Subgroup 1 (15 subjects) : STAI Y2 anxiety score > 61
Subgroup 2 (15 subjects) : STAI Y2 anxiety score < 51

Inclusion criteria - Female control subjects (15 subjects)

BMI between 18.5 and 25 kg/ m²
Absence of a psychological profile of eating disorder or other psychiatric disorders.

Exclusion Criteria:

Subjects with an oral contraception and breastfeeding woman
Subject with heart failure
Subject treated during the last three months with neuroleptics, and antiparkinsonian drugs, monoamine oxidase (MAO)-A or monoamine oxidase (MOA)-B inhibitors, tricyclic antidepressants, 5HT reuptake inhibitors, thymo regulators (lithium), antiepileptic dugs, codeine derivatives, morphinics, tramadol-containing products (Topalgic, …),dopaminergic drugs.
Subjects with suspected pregnancy; Test β human chorionic gonadotropin (HCG) positive prior to examination.
Subjects for whom MRI is contraindicated (pacemaker, intracerebral clips, prosthesis made of ferromagnetic material or claustrophobia).
Subjects unable to sign written consent for participation in the study.
Subject deprived of liberty by a judicial or administrative decision