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

Centre Hospitalier St Anne

Status and phase: Not yet enrolling; Phase 2

Conditions: Anorexia Nervosa Restricting Type

Treatments: Drug: Donepezil 2.5 mg; Drug: Placebo Comparator; Drug: Donepezil 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06687993

D22-P020

2024-511681-37-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 147 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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147 participants in 3 patient groups, including a placebo group

donepezil 2.5 mg

Experimental group

Description:

donepezil 2.5 mg daily for 90 days

Treatment:

Drug: Donepezil 2.5 mg

donepezil 5 mg

Experimental group

Description:

donepezil 5 mg daily for 90 days

Treatment:

Drug: Donepezil 5 mg

placebo

Placebo Comparator group

Description:

placebo daily for 90 days

Treatment:

Drug: Placebo Comparator