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Study on the Role of Serotonin and Sodium Chloride in Brain Circuits for Food Avoidance in Patients with Anorexia Nervosa

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What is this study about?

This clinical trial focuses on understanding the role of serotonin in the brain circuits involved in food avoidance in individuals with anorexia nervosa. Anorexia nervosa is a serious eating disorder characterized by an intense fear of gaining weight and a distorted body image, leading to restricted food intake and excessive weight loss. The study aims to explore how serotonin, a chemical in the brain that affects mood and behavior, influences the brain’s control over food intake.

The study will use a combination of advanced imaging techniques, including PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging), to observe brain activity and structure. Participants will undergo these imaging tests to measure serotonin activity and brain connectivity. The trial will also involve eye-tracking to study gaze patterns during food choice tasks, as well as questionnaires to assess eating behaviors and anxiety levels.

The purpose of the study is to evaluate differences in serotonin transmission in the brain networks that control food intake between individuals with anorexia nervosa and those without the disorder. The trial will help researchers better understand the underlying brain mechanisms of anorexia nervosa, potentially leading to improved treatments in the future. Participants will receive an injection of sodium chloride solution as part of the study procedures.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age, anxiety levels, body mass index (BMI), and the absence of certain psychological profiles.

Participants will be required to sign a written consent form and provide proof of affiliation with a social security scheme.

2 baseline measurements

Baseline measurements will be taken to establish initial health and psychological status. This includes psychometric scales to assess eating disorders and anxiety, such as the Eating Disorder Inventory (EDI) and the Spielberger Anxiety Scale (STAI).

Hormonal and nutritional parameters will also be measured.

3 imaging procedures

Participants will undergo various imaging procedures to study brain activity and structure. This includes positron emission tomography (PET) to measure serotonergic transmission and magnetic resonance imaging (MRI) to assess brain connectivity and activity.

Functional MRI will be used to measure brain activity levels during rest and task performance.

4 eye tracking and food preference tests

Participants will take part in tests to measure food choice and preferences. Eye movements and gaze fixation on food items will be tracked using a TOBII-type eye tracker.

Avoidance and approach indices, as well as time spent looking at different food categories, will be recorded.

5 follow-up assessments

Follow-up assessments will be conducted to monitor changes in psychological and physiological parameters. This includes repeating some of the initial tests and measurements.

Participants’ responses to various proposals during food choice tests will be evaluated.

Who Can Join the Study?

  • Women aged between 18 and 35 years old.
  • Body Mass Index (BMI) between 18.5 and 25 kg/m². BMI is a measure of body fat based on height and weight.
  • No psychological profile of eating disorder or other psychiatric disorders.
  • Low level of trait anxiety, which means a score of less than 51 on the STAI-YB anxiety test. This test measures anxiety levels.
  • Must sign a written consent form agreeing to participate in the study.
  • Must be affiliated with or entitled to a social security scheme.
  • Fear of weight gain.
  • Dismorphophobia, which is a condition where a person is excessively concerned about and preoccupied with a perceived defect in their physical appearance.
  • BMI less than 17.5 kg/m².
  • Amenorrhea, which means the absence of menstruation.
  • No food compulsions or purges, meaning no uncontrollable urges to eat or to get rid of food from the body.
  • For Subgroup 1: STAI Y2 anxiety score greater than 51.
  • For Subgroup 2: STAI Y2 anxiety score less than 51.

Who Cannot Join the Study?

  • Participants must not have any other serious medical conditions that could interfere with the study.
  • Participants must not be taking medications that affect the brain’s serotonin system. Serotonin is a chemical in the brain that helps regulate mood and appetite.
  • Participants must not have a history of substance abuse or addiction.
  • Participants must not be pregnant or breastfeeding.
  • Participants must not have any psychiatric disorders other than anorexia nervosa.
  • Participants must not have any neurological disorders, which are conditions that affect the brain and nerves.
  • Participants must not have any significant abnormalities in brain structure, which could be detected by imaging tests like MRI or CT scans.
  • Participants must not have participated in another clinical trial within the last 30 days.

Where you can join this trial?

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Site Name City Country Status
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Trial status

Country Status Recruitment Start
France France
Not recruiting
10.12.2021

Trial locations

Investigated drugs:

Serotonin is a natural chemical in the brain that helps regulate mood, appetite, and digestion. In this study, researchers are looking at how serotonin affects brain circuits related to food avoidance in people with anorexia nervosa. By using a special type of brain scan called PET, they aim to understand how serotonin levels differ between people with anorexia and those without the condition. This could help in understanding the role of serotonin in controlling food intake and potentially lead to better treatments for anorexia.

Investigated diseases:

Anorexia Nervosa – Anorexia Nervosa is an eating disorder characterized by an intense fear of gaining weight and a distorted body image, leading to restricted food intake and excessive weight loss. Individuals with this condition often see themselves as overweight, even when they are underweight. The disorder typically begins during adolescence and can progress to severe malnutrition. As the condition advances, individuals may experience physical symptoms such as thinning bones, brittle hair and nails, and severe constipation. Psychological symptoms can include irritability, social withdrawal, and a preoccupation with food and dieting. Over time, the disorder can affect various bodily systems, leading to complications such as heart problems and weakened muscles.

Trial ID:
2024-519848-33-00
Protocol code:
20CH240
NCT ID:
NCT05155280
Trial Phase:
Therapeutic confirmatory (Phase III)

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