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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05155280
Acronym
SEVIALANO
Enrollment
57
Registered
2021-12-13
Start date
2021-12-10
Completion date
2025-07-08
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa, serotonin, PET-MRI, eating disorders

Brief summary

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

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.

Interventions

OTHERPET 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.

BEHAVIORALEye 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Pathophysiological comparative study

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting stateDay 2serotonin 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 2serotonin 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 activityDay 2brain 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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBogdan GALUSCA, PhD

Centre Hospitalier Universitaire de Saint Etienne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026