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TerminatedPhase 3

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

Key facts

Who runs it
Centre Hospitalier Universitaire de Saint Etienne
Where
France1 site in 1 countryChoose a country to see its sites
Status
Terminated
Phase
Phase 3
People taking part
57 people enrolled
Started
10 Dec 2021
Ended
8 Jul 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • PET imaging using [11C]DASB radioligand.
  • Eye Tracker
Record updated
6 February 2026
Why it stopped
The sponsor received the following instruction from the ANSM : "The sponsor shall conduct toxicity studies in accordance with the applicable guidelines, in particular " ICH guideline M3 (R2) on non-clinical safety studies for the conduct of human cli

Who can take part

Age
16 years to 35 years
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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
  • BMI between 18.5 and 25 kg/ m²
  • Absence of a psychological profile of eating disorder or other psychiatric disorders

Who cannot take part

  • 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
  • Subject with heart failure
  • Subjects with an oral contraception and breastfeeding woman
  • 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

Other criteria

  • Common Criteria for inclusion :
  • Signature of written consent
  • Subject affiliated or entitled to a social security scheme

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Anorexia Nervosa patientsTreatment being tested

    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: PET imaging using [11C]DASB radioligand. and Eye Tracker

  • ControlsPlacebo, for comparison

    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: PET imaging using [11C]DASB radioligand. and Eye Tracker

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa : Study of Gaze Control and Multimodal Brain Imaging
Record updated
6 February 2026