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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Saint Etienne

Participant type

Pediatric, Patients, Healthy volunteers

Age range

0-17 years, 18-64 years

Gender

Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

completed 8 Jul 2025

Decision date (initial)

2025-01-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-519848-33-00

EudraCT number

2021-000906-10

ClinicalTrials.gov

NCT05155280

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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.

Secondary objectives 6

1. Evaluate differences in brain activity measured by MRI (simultaneously with PET scans) in the cerebral networks underlying the control of food intake between anorexic control subjects.
2. To determine potential correlative links between abnormalities in serotonergic serotonergic transmission measured with [11C]DASB in PET PET scans and abnormalities in brain activity measured on fMRI in the activity measured in fMRI at rest (resting state) or during activation food choice tasks using simultaneous PET-MRI imaging.
3. To determine the influence of anxiety on cerebral anomalies by studying two subgroups in the group of 30 patients. subgroups, one subgroup of patients with an anxious profile and another with a non-anxious profile.
4. Using a non-invasive eye-tracking approach during food preference and choice tests, the degree of active of expression of active avoidance in anorexic patients in comparison with matched healthy subjects and in relation to their anxiety level.
5. Determine potential correlative links between abnormalities in serotonergic serotonergic transmission as measured by [11C]DASB PET, abnormalities in brain activity measured by fMRI and the intensity of active avoidance measured by the non-invasive eye-tracking approach.
6. Determine potential correlative links between abnormalities in serotonergic serotonergic transmission as measured by [11C]DASB PET, abnormalities in brain activity measured by fMRI and hormonal and nutritional parameters.

Conditions and MedDRA coding

Anorexia Nervosa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. 16-35 year old women
2. Signature of written consent
3. Subject affiliated or entitled to a social security scheme
4. Fear of weight gain
5. Dismorphophobia
6. BMI < 17.5 kg/ m²
7. Amenorrhea
8. Absence of food compulsions and purges
9. Subgroup 1: STAI Y2 anxiety score > 51
10. Subgroup 2: STAI Y2 anxiety score < 51
11. BMI between 18.5 and 25 kg/ m²
12. Absence of a psychological profile of eating disorder or other psychiatric disorders.
13. A low level of trait anxiety (< 51 on the STAI-YB) matched the group of patients with the same level.

Exclusion criteria 8

1. Subjects with an oral contraception
2. Breastfeeding woman
3. Subject with heart failure
4. 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.
5. Subjects with suspected pregnancy; Test β HCG positive prior to examination.
6. Subjects for whom MRI is contraindicated (pacemaker, intracerebral clips, prosthesis made of ferromagnetic material or claustrophobia).
7. Subjects unable to sign written consent for participation in the study
8. Subject deprived of liberty by a judicial or administrative decision

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 9

1. Resting-state functional MRI measurement of cerebral blood flow quantified by ArterialSpin Labelling (ASL) to assess cerebral perfusion (regional cerebral blood flow).
2. Resting-state MRI measurement of water diffusion in white matter to assess structural brain connectivity structural brain connectivity, in DTI (diffusion tensor imaging) mode
3. Resting-state functional MRI measurement of white matter water Diffusion for the assessment of structural structural brain connectivity, in DTI (diffusion tensor imaging) mode
4. 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.
5. The subjects' responses (subjective measures) to the various proposals made during the food choice and preference preferences.
6. 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).
7. Psychometric scales to characterize eating disorders and anxiety: EDI (Eating Disorder Inventory), DEBQ (Dutch Inventory), DEBQ (Dutch Eating Behavior Questionnaire), Spielberger Anxiety Scale (STAI)
8. 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.
9. Hormonal and nutritional parameters.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Saint Etienne

Sponsor organisation

Centre Hospitalier Universitaire De Saint Etienne

Address

Avenue Albert Raimond

City

Saint Priest En Jarez

Postcode

42270

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Saint Etienne

Contact name

Project manager

Public contact point

Organisation

Centre Hospitalier Universitaire De Saint Etienne

Contact name

Project manager

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications