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

NCT05155280 | Terminated

• 2 other identifiers: 20CH2402021-000906-10
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa; serotonin; PET-MRI; eating disorders

Outcome Measures

Primary Outcomes (1)

• difference between the two groups of the study for serotonin binding potential

  The difference in serotonin binding potential is measured by PET scan of the brain networks between anorexic and control subjects.

  Day 2

Secondary Outcomes (3)

• correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state

  Day 2

• correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks.

  Day 2

• correlation between anxiety profile and brain activity

  Day 2

Study Arms (2)

Anorexia Nervosa patients

EXPERIMENTAL

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.; Behavioral: Eye Tracker

Controls

PLACEBO COMPARATOR

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

Interventions

Eye Tracker 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.

Anorexia Nervosa patients; Controls

PET imaging using [11C]DASB radioligand. 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.

Anorexia Nervosa patients; Controls

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bogdan GALUSCA, PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pathophysiological comparative study

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 13, 2021
• Study Start: December 10, 2021
• Primary Completion: July 4, 2025
• Study Completion: July 8, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)