Acetylcholinesterase Inhibitor in Anorexia Nervosa: Multicenter, Double-Blind, Placebo-Controlled Trial

Launched by CENTRE HOSPITALIER ST ANNE · Nov 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called donepezil can help adult women with anorexia nervosa, particularly those who have the restricting type of the condition. The main goal is to see if taking donepezil daily for three months can lead to weight gain and help reduce food restriction behaviors. Donepezil is a drug that has been used for other health issues and works by affecting a brain chemical called acetylcholine. In this trial, participants will take either donepezil or a placebo (a sugar pill that looks the same) every day, and they will have regular check-ups to monitor their health and well-being.

To be eligible for this trial, women must be between 18 and 65 years old, have a specific diagnosis of anorexia nervosa with a body mass index (BMI) between 15 and 18.5, and meet other health criteria. Participants will be required to use an effective method of birth control and provide written consent to join the study. During the trial, they can expect to take a capsule daily and attend regular hospital visits for assessments. It’s important to note that certain health conditions or past diagnoses may exclude individuals from participating, so potential participants should discuss their specific situation with their healthcare provider.

Gender

FEMALE

Eligibility criteria

• 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 cytochromes: P450, P3A4, P2D6
• • Known hypersensitivity to donepezil hydrochloride, piperidine derivatives, or any excipients of the investigational drug
• • Pregnant or breastfeeding woman
• • Person under legal protection measures
• • Person under guardianship measures