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

Anorexia Nervosa Clinical Trial

— SEVIALANO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155280
• Other study ID #: 20CH240
• Secondary ID: 2021-000906-10
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Bogdan GALUSCA, PhD
• Phone: (0)477127727
• Email: bogdan.galusca[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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 ß 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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state	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	Day 2
Secondary	correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks.	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.	Day 2
Secondary	correlation between anxiety profile and brain activity	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	Day 2