Clinical trial NCT05155280: Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa
Official title: Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa : Study of Gaze Control and Multimodal Brain Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
serotonin
PET-MRI
eating disorders
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 75
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pathophysiological comparative study
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: difference between the two groups of the study for serotonin binding potential
timeFrame: Day 2
Secondary outcomes:
measure: correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state
timeFrame: Day 2
measure: correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks.
timeFrame: Day 2
measure: correlation between anxiety profile and brain activity
timeFrame: Day 2
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Bogdan GALUSCA, PhD
role: PRINCIPAL_INVESTIGATOR
References: