Clinical trial NCT06687993: Acetylcholinesterase Inhibitor in Anorexia Nervosa: Multicenter, Double-Blind, Placebo-Controlled Trial
Official title: Acetylcholinesterase Inhibitor Treatment in Anorexia Nervosa: a Multicenter, Double-Blind, Placebo-Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Anorexia Nervosa Restricting Type
Keywords: anorexia nervosa
eating disorders
donepezil
habits
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: Université Paris Cité
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2024-11-14
Enrollment: 147
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multicenter, superiority study, in double-blind, randomized, parallel groups, controlled versus placebo, in using a sequential adaptive design by band.
Primary purpose: TREATMENT

Brief 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.


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 \&gt; 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

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