Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa (SEVIALANO)

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Anorexia Nervosa

Treatments: Behavioral: Eye Tracker; Other: PET imaging using [11C]DASB radioligand.

Study type: Interventional

Funder types: Other

Identifiers

NCT05155280

20CH240

2021-000906-10 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

57 participants in 2 patient groups, including a placebo group

Anorexia Nervosa patients

Experimental group

Description:

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.

Treatment:

Other: PET imaging using [11C]DASB radioligand.

Behavioral: Eye Tracker

Controls

Placebo Comparator group

Description:

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.

Treatment:

Other: PET imaging using [11C]DASB radioligand.

Behavioral: Eye Tracker