Acetylcholinesterase Inhibitor in Anorexia Nervosa: Multicenter, Double-Blind, Placebo-Controlled Trial
147 participantsStarted 2024-11
Plain-language summary
The goal of this clinical trial is to learn if the daily take of donepezil can treat adult patient suffering from anorexia nervosa. The main question it aims to answer is : do daily donepezil intake permit weight gain and reduction of food restriction rituals ? The treatment is a capsule comprising a drug limiting the degradation of a neurotransmitter called acetylcholine. This treatment has long been used to treat certain cognitive disorders. Researchers will compare two drug dosage and a look-alike capsule that contains no drug to see if the dose has an impact on the effect. Participants will take one capsule per day for three months will have regular hospital visits for cognitive and metabolic tests.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female
* Presence of the 3 DSM-V criteria for Anorexia Nervosa
* Restrictive subtype of Anorexia Nervosa according to DSM-5
* Body Mass Index between 15 and 18.5 kg/m²
* Aged 18 to 65 years
* Resting heart rate \> or = 40 bpm
* Use of a highly effective contraceptive method
* Affiliation or entitlement to a Health Insurance scheme
* Prior free, informed, and written consent
Exclusion Criteria:
* Presence of one or more somatic criteria for hospitalization according to french HAS 2010 guidelines
* Past diagnosis of anorexia nervosa with binge-eating/purging type
* Past diagnosis of bulimia nervosa
* Past diagnosis of binge-eating disorder
* Associated diagnosis of schizophrenia and/or persistent delusional disorder and/or bipolar disorder
* History of asthma or obstructive bronchopulmonary disease
* History of peptic ulcer disease or concurrent treatment with non-steroidal anti-inflammatory drugs
* History of epileptic disorders
* Renal insufficiency (glomerular filtration rate less than 60 mL/min according to the MDRD formula)
* Hepatic insufficiency or transaminase levels greater than 5 times the normal upper limit
* Conductance disorder characterized by electrocardiogram
* QTc according to Bazett's formula greater than 480 ms on electrocardiogram
* Current or recent (within three weeks prior to inclusion) psychotropic treatment (including antidepressants, to avoid interaction/potentiation in this population)
* Treatment involving the following cy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect on Body Mass Index in adult women suffering from anorexia nervosa
Timeframe: Before (D0) and after 90 days of treatment