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Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa (SEVIALANO)

Primary Purpose

Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET imaging using [11C]DASB radioligand.
Eye Tracker
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa focused on measuring anorexia nervosa, serotonin, PET-MRI, eating disorders

Eligibility Criteria

16 Years - 35 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anorexia Nervosa patients

Controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
December 1, 2021
Last Updated
July 24, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT05155280
Brief Title
Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa
Acronym
SEVIALANO
Official Title
Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa : Study of Gaze Control and Multimodal Brain Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
anorexia nervosa, serotonin, PET-MRI, eating disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pathophysiological comparative study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anorexia Nervosa patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Controls
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PET imaging using [11C]DASB radioligand.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Eye Tracker
Intervention Description
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.
Primary Outcome Measure Information:
Title
difference between the two groups of the study for serotonin binding potential
Description
The difference in serotonin binding potential is measured by PET scan of the brain networks between anorexic and control subjects.
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state
Description
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
Time Frame
Day 2
Title
correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks.
Description
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.
Time Frame
Day 2
Title
correlation between anxiety profile and brain activity
Description
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
Time Frame
Day 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bogdan GALUSCA, PhD
Phone
(0)477127727
Ext
+33
Email
bogdan.galusca@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence RANCON, CRA
Phone
(0)477120826
Ext
+33
Email
florence.rancon@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bogdan GALUSCA, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan GALUSCA, PhD
First Name & Middle Initial & Last Name & Degree
Florence RANCON, CRA
First Name & Middle Initial & Last Name & Degree
Catherine MASSOUBRE, PhD
First Name & Middle Initial & Last Name & Degree
Natacha GERMAIN, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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