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Not yet recruiting NCT06687993

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

Phase II Interventional Anorexia Nervosa Restricting Type

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Donepezil 2.5 mg, Donepezil 5 mg, Placebo Comparator.
Who it may be relevant to
Registry conditions: Anorexia Nervosa Restricting Type. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Donepezil 2.5 mg
    2.5 mg daily oral intake for 90 days
  • Drug Donepezil 5 mg
    5 mg daily oral intake for 90 days
  • Drug Placebo Comparator
    daily oral intake for 90 days

Primary outcome measures

  • Effect on Body Mass Index in adult women suffering from anorexia nervosa [Time frame: Before (D0) and after 90 days of treatment]
Secondary outcome measures (10)
  • Effect on eating disorder symptomatology in adult women suffering from anorexia nervosa: difference of Eating Disorder Examination Questionnaire (EDE-Q) score [Time frame: Before (D0) and after 90 days of treatment]
  • Effects on habits learning in adult women suffering from anorexia nervosa: difference of phase 3 of slips-of-action neurocognitive test [Time frame: Before (D0) and after 90 days of treatment]
  • Effect on balance between goal-directed behaviors and habits in adult women suffering from anorexia nervosa: difference of total score in Self-Report Habit Index [Time frame: Before (D0) and after 90 days of treatment]
  • Effect on cognitive flexibility in adult women suffering from anorexia nervosa: difference in Wisconsin Card Sorting Test [Time frame: Before (D0) and after 90 days of treatment]
  • Effect on cognitive flexibility in adult women suffering from anorexia nervosa: difference in Trail Making Test B-A, Brixton Test [Time frame: Before (D0) and after 90 days of treatment]
  • Effect on compulsive and obsessive in adult women suffering from anorexia nervosa: difference in Yale-Brown Obsessive Compulsive Scale [Time frame: Before (D0) and after 90 days of treatment]
  • Effect on main eating disorder dimensions in adult suffering from anorexia nervosa: difference in subdimensions on EDE-Q and Eating Disorder Iventory 3 [Time frame: Before (D0) after 90 days of treatment and 90 days after stopping treatment]
  • Effect on depressive and anxious symptoms in adult women suffering from anorexia nervosa: difference on Hospital Anxiety and Depression Scale (HADS) [Time frame: Before (D0) and after 90 days of treatment]
  • Measure the toxicity and tolerance of donepezil in adult women suffering from anorexia nervosa [Time frame: D3, D5, D30, D90]
  • Biological factors associated with response to treatment [Time frame: Before (D0) and after 90 days of treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06687993 · D22-P020 · 2024-511681-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗