Study on the Effects of Donepezil in Patients with Anorexia Nervosa

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What is this study about?

This clinical trial is focused on studying the effects of a medication called on individuals with . Anorexia nervosa is a condition 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 evaluate how donepezil, which is an , can help improve the symptoms associated with anorexia nervosa. Donepezil is commonly used to treat symptoms of Alzheimer’s disease by increasing the levels of a chemical in the brain that is important for memory and learning.

Participants in the study will receive either donepezil or a , which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations. The treatment will be administered orally, and the study will last for a period of three months, during which participants will be monitored for changes in their symptoms and overall health.

The primary goal of the study is to observe any improvements in the symptoms of anorexia nervosa, such as changes in eating habits and body image perception. Additionally, the study will track other health indicators, including body mass index and psychological assessments, to gather comprehensive data on the effects of donepezil. Participants will undergo various tests and assessments at different points throughout the study to measure these changes. The study will also monitor for any potential side effects or adverse reactions to the medication. The findings from this trial could provide valuable insights into new treatment options for individuals with anorexia nervosa.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, body mass index, and heart rate.

The study is designed for females with anorexia nervosa, specifically the restrictive subtype.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes the Eating Disorder Examination Questionnaire (EDE-Q) score and other psychological and physical health assessments.

3 medication administration

Participants receive either donepezil or a placebo. Donepezil is administered orally in the form of a 5 mg film-coated tablet.

The medication is taken daily for the duration of the study.

4 follow-up assessments

Follow-up assessments occur at various intervals: Day 3, Day 5, Day 30, Day 90, and Day 180.

These assessments include monitoring changes in body mass index, psychological tests, and the occurrence of any adverse events.

5 primary outcome evaluation

The primary outcome is evaluated by measuring the change in the EDE-Q score from the start of the study (Day 0) to Day 90.

6 secondary outcome evaluation

Secondary outcomes include changes in body mass index, psychological test scores, and the occurrence of adverse events.

These are assessed at various points throughout the study, including Day 90 and Day 180.

7 completion of the study

The study concludes with a final assessment to evaluate the overall impact of the treatment on anorexia nervosa symptoms.

Participants’ data is collected and analyzed to determine the effectiveness of donepezil compared to the placebo.

Who Can Join the Study?

  • Must be female.
  • Must have 3 DSM V criteria for anorexia nervosa. DSM V is a guide used by doctors to diagnose mental health conditions.
  • Must have the restrictive subtype of anorexia nervosa, which means limiting food intake.
  • Must have a Body Mass Index (BMI) between 14 and 18.5 kg/m². BMI is a number calculated from a person’s weight and height.
  • Must be aged between 18 and 65 years old.
  • Must have a resting heart rate of 40 beats per minute (bpm) or higher. Resting heart rate is the number of heartbeats per minute when you are at rest.

Who Cannot Join the Study?

  • Individuals who are not female cannot participate in the study.
  • Individuals who are not within the specified age range cannot participate in the study.
  • Individuals who are part of a vulnerable population cannot participate in the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital Paul Brousse Villejuif France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.07.2024

Trial locations

Investigated drugs:

Donepezil is a medication used in this trial to help improve symptoms of anorexia nervosa. It works by increasing levels of a certain natural substance in the brain, which may help with memory and thinking. In this study, researchers are testing whether donepezil can help people with anorexia nervosa feel better compared to those who do not receive the medication.

Investigated diseases:

Anorexia nervosa – Anorexia nervosa is an eating disorder characterized by an intense fear of gaining weight and a distorted body image, leading individuals to restrict food intake severely. This condition often results in significant weight loss and malnutrition. People with anorexia nervosa may engage in excessive exercise, use laxatives, or induce vomiting to control their weight. The disorder can affect various bodily functions, including hormonal imbalances and weakened bones. Psychological symptoms such as anxiety and obsessive behaviors are also common. Over time, the physical and mental health impacts can become more pronounced if the disorder persists.

Trial ID:
2024-511681-37-00
Protocol code:
D22-P020
Trial Phase:
Therapeutic exploratory (Phase II)

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