Serotonin role on brain circuits involved in food avoidance in anorexia nervosa : Study of Gaze control and multimodal Brain imaging.

Phase 3

Not yet recruiting

Conditions: Anorexia Nervosa

Registration Number: 2024-519848-33-00

Lead Sponsor: Centre Hospitalier Universitaire De Saint Etienne

Brief Summary: To evaluate differences in serotonergic transmission measured by PET at the levels of the cerebral networks underlying the control of food intake (including the striatum) between anorexic and control subjects.

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.

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Female

Target Recruitment: 75

Inclusion Criteria

18-35 year old women

Subgroup 2: 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.

A low level of trait anxiety (< 51 on the STAI-YB) matched the group of patients with the same level.

Signature of written consent

Subject affiliated or entitled to a social security scheme

Fear of weight gain

Dismorphophobia

BMI < 17.5 kg/ m²

Amenorrhea

Absence of food compulsions and purges

Subgroup 1: STAI Y2 anxiety score > 51

Exclusion Criteria

Subjects with an oral contraception

Breastfeeding woman

Subject with heart failure

Subject treated during the last three months with neuroleptics, and antiparkinsonian drugs, MAO-A or MOA-B inhibitors, tricyclic antidepressants, 5HT reuptake inhibitors, thymoregulators (lithium), antiepileptic dugs, codeine derivatives, morphinics, tramadol-containing products (Topalgic, lxprim…),dopaminergic drugs.

Subjects with suspected pregnancy; Test β 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BPND, the unit for measuring the non-displaceable binding potential of the [11C] DASB in PET imaging		BPND, the unit for measuring the non-displaceable binding potential of the [11C] DASB in PET imaging

Secondary Outcome Measures

Name	Time	Method
Resting-state functional MRI measurement of cerebral blood flow quantified by ArterialSpin Labelling (ASL) to assess cerebral perfusion (regional cerebral blood flow).		Resting-state functional MRI measurement of cerebral blood flow quantified by ArterialSpin Labelling (ASL) to assess cerebral perfusion (regional cerebral blood flow).
Resting-state MRI measurement of water diffusion in white matter to assess structural brain connectivity structural brain connectivity, in DTI (diffusion tensor imaging) mode		Resting-state MRI measurement of water diffusion in white matter to assess structural brain connectivity structural brain connectivity, in DTI (diffusion tensor imaging) mode
Resting-state functional MRI measurement of white matter water Diffusion for the assessment of structural structural brain connectivity, in DTI (diffusion tensor imaging) mode		Resting-state functional MRI measurement of white matter water Diffusion for the assessment of structural structural brain connectivity, in DTI (diffusion tensor imaging) mode
Functional MRI measurement of brain activity levels by BOLD in the resting state and during task performance simultaneously with PET acquisition, thanks to the hybrid PET-MRI CAMERA.		Functional MRI measurement of brain activity levels by BOLD in the resting state and during task performance simultaneously with PET acquisition, thanks to the hybrid PET-MRI CAMERA.
The subjects' responses (subjective measures) to the various proposals made during the food choice and preference preferences.		The subjects' responses (subjective measures) to the various proposals made during the food choice and preference preferences.
Avoidance and approach indices, as well as indices of time spent looking at items in different food categories, measured by tracking eye movements and gaze fixation on food items presented during food choice and preference tests (using a TOBII-type eye tracker).		Avoidance and approach indices, as well as indices of time spent looking at items in different food categories, measured by tracking eye movements and gaze fixation on food items presented during food choice and preference tests (using a TOBII-type eye tracker).
Psychometric scales to characterize eating disorders and anxiety: EDI (Eating Disorder Inventory), DEBQ (Dutch Inventory), DEBQ (Dutch Eating Behavior Questionnaire), Spielberger Anxiety Scale (STAI)		Psychometric scales to characterize eating disorders and anxiety: EDI (Eating Disorder Inventory), DEBQ (Dutch Inventory), DEBQ (Dutch Eating Behavior Questionnaire), Spielberger Anxiety Scale (STAI)
Beck Depression Scales, to measure and monitor subjects' depressive state which can be a confounding factor, since it is frequently since it is frequently associated with anxiety.		Beck Depression Scales, to measure and monitor subjects' depressive state which can be a confounding factor, since it is frequently since it is frequently associated with anxiety.
Hormonal and nutritional parameters.		Hormonal and nutritional parameters.

Trial Locations

Locations (1): Centre Hospitalier Universitaire De Saint Etienne
🇫🇷
Saint Priest En Jarez, France
Centre Hospitalier Universitaire De Saint Etienne
🇫🇷Saint Priest En Jarez, France
Bogdan GALUSCA
Site contact
+33477127727
bogdan.galusca@chu-st-etienne.fr