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

NCT ID: NCT05155280

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2025-07-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Pathophysiological comparative study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PET imaging using [11C]DASB radioligand.

Intervention Type OTHER

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.

Eye Tracker

Intervention Type BEHAVIORAL

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.

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.

Group Type PLACEBO_COMPARATOR

PET imaging using [11C]DASB radioligand.

Intervention Type OTHER

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.

Eye Tracker

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


* 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


* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bogdan GALUSCA, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2021-000906-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20CH240

Identifier Type: -

Identifier Source: org_study_id

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