- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05155280
Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa (SEVIALANO)
Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa : Study of Gaze Control and Multimodal Brain Imaging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bogdan GALUSCA, PhD
- Phone Number: +33 (0)477127727
- Email: bogdan.galusca@chu-st-etienne.fr
Study Contact Backup
- Name: Florence RANCON, CRA
- Phone Number: +33 (0)477120826
- Email: florence.rancon@chu-st-etienne.fr
Study Locations
-
-
-
Saint-Étienne, France, 42055
- Recruiting
- CHU de Saint-Etienne
-
Sub-Investigator:
- Natacha GERMAIN, PhD
-
Contact:
- Florence RANCON, CRA
-
Contact:
- Bogdan GALUSCA, PhD
-
Sub-Investigator:
- Catherine MASSOUBRE, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anorexia Nervosa patients
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. |
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.
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.
|
Placebo Comparator: Controls
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state
Time Frame: Day 2
|
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
|
Day 2
|
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks.
Time Frame: Day 2
|
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.
|
Day 2
|
correlation between anxiety profile and brain activity
Time Frame: Day 2
|
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 |
Day 2
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bogdan GALUSCA, PhD, Centre Hospitalier Universitaire de Saint Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20CH240
- 2021-000906-10 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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