Anorexia NervosaSEVIALANONCT05155280
Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa
A study testing PET imaging using [11C]DASB radioligand. and Eye Tracker in people with Anorexia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Serotoninergic activity in brain structures involved in food control and avoidance, such as the basal ganglia, is poorly understood in Anorexia Nervosa. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- PET imaging using [11C]DASB radioligand. and Eye Tracker
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2021to 8 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- BMI between 18.5 and 25 kg/ m²
- Absence of a psychological profile of eating disorder or other psychiatric disorders.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa : Study of Gaze Control and Multimodal Brain Imaging
Serotoninergic activity in brain structures involved in food control and avoidance, such as the basal ganglia, is poorly understood in Anorexia Nervosa.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- PET imaging using [11C]DASB radioligand., Eye Tracker
- Keywords
- anorexia nervosa, serotonin, PET-MRI, eating disorders
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imaging using [11C]DASB radioligand.Other
Subjects will be asked to complete a food choice task in PET/MRI. During the task, PET and MRI scans will be acquired simultaneously. This will allow us to see in real time during food choices the brain activations of the subjects. For imaging we will inject the DASB tracer intravenously. This radio ligand is a tracer that allows us to see the cerebral serotoninergic transmission by positron emission tomography.
Eye TrackerBehavioural
The second technique used is the eye tracker that will allow us to analyze food avoidance behaviors through the eyes. With a "TOBII" eye tracker we wil be able to follow the gaze of the subjects during the food preference task. It is a non-invasive approach.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa patients | Experimental | 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. Receives: Other: PET imaging using [11C]DASB radioligand.; Behavioral: Eye Tracker |
| Controls | Placebo comparator | 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. Receives: Other: PET imaging using [11C]DASB radioligand.; Behavioral: Eye Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between the two groups of the study for serotonin binding potential
The difference in serotonin binding potential is measured by PET scan of the brain networks between anorexic and control subjects.
Measured: Day 2
Secondary outcomes (3)
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state
serotonin binding potential is measured with [11C]DASB PET. abnormalities in brain activity is measured on fMRI. correlation between abnormalities in serotonin binding potential and abnormalities in brain activity is quantified by change in the resting state
Measured: Day 2
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks.
serotonin binding potential is measured with [11C]DASB PET. abnormalities in brain activity is measured on fMRI. correlation between abnormalities in serotonin binding potential and abnormalities in brain activity is quantified by change during the food choice tasks.
Measured: Day 2
correlation between anxiety profile and brain activity
brain activity is measured on fMRI and anxiety is measured by the score STAI YB.
STAI YB > 51 = Moderate to high anxiety STAI YB<51 = Low anxiety
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start10 Dec 2021
- Primary completion4 Jul 2025
- Study completion8 Jul 2025
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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pathophysiological comparative study
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bogdan GALUSCA, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155280
- Sponsor's protocol ID
- 20CH240
- Other IDs
- 2021-000906-10
- Acronym
- SEVIALANO
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa : Study of Gaze Control and Multimodal Brain Imaging
- ClinicalTrials.gov ID
- NCT05155280
- Acronym / sponsor ID
- SEVIALANO / 20CH240
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, serotonin, PET-MRI, eating disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pathophysiological comparative study
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa patients | Experimental | Other: PET imaging using [11C]DASB radioligand., Behavioral: Eye Tracker30 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. |
| Controls | Placebo comparator | Other: PET imaging using [11C]DASB radioligand., Behavioral: Eye Tracker15 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. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- BMI between 18.5 and 25 kg/ m²
- Absence of a psychological profile of eating disorder or other psychiatric disorders.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET imaging using [11C]DASB radioligand.Subjects will be asked to complete a food choice task in PET/MRI. During the task, PET and MRI scans will be acquired simultaneously. This will allow us to see in real time during food choices the brain activations of the subjects. For imaging we will inject the DASB tracer intravenously. This radio ligand is a tracer that allows us to see the cerebral serotoninergic transmission by positron emission tomography. | Other | Anorexia Nervosa patients, Controls |
| Eye TrackerThe second technique used is the eye tracker that will allow us to analyze food avoidance behaviors through the eyes. With a "TOBII" eye tracker we wil be able to follow the gaze of the subjects during the food preference task. It is a non-invasive approach. | Behavioural | Anorexia Nervosa patients, Controls |
Primary outcome
difference between the two groups of the study for serotonin binding potential
Time frame: Day 2
The difference in serotonin binding potential is measured by PET scan of the brain networks between anorexic and control subjects.
3 secondary outcomes
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state
Time frame: Day 2
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks.
Time frame: Day 2
correlation between anxiety profile and brain activity
Time frame: Day 2
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogdan GALUSCA, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET imaging using [11C]DASB radioligand. and Eye Tracker in people with Anorexia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference between the two groups of the study for serotonin binding potential (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.