Acetylcholinesterase Inhibitor in Anorexia Nervosa: Multicenter, Double-Blind, Placebo-Controlled Trial
ANACh
2 other identifiers
interventional
147
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2024
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
November 14, 2024
July 1, 2024
5.3 years
September 30, 2024
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect on Body Mass Index in adult women suffering from anorexia nervosa
Difference of Body Masse Index between inclusion (D0) and the end of treatment (D90)
Before (D0) and after 90 days of treatment
Secondary Outcomes (10)
Effect on eating disorder symptomatology in adult women suffering from anorexia nervosa: difference of Eating Disorder Examination Questionnaire (EDE-Q) score
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
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
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
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
Before (D0) and after 90 days of treatment
- +5 more secondary outcomes
Study Arms (3)
donepezil 2.5 mg
EXPERIMENTALdonepezil 2.5 mg daily for 90 days
donepezil 5 mg
EXPERIMENTALdonepezil 5 mg daily for 90 days
placebo
PLACEBO COMPARATORplacebo daily for 90 days
Interventions
2.5 mg daily oral intake for 90 days
5 mg daily oral intake for 90 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier St Annelead
- Université Paris Citécollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind design. Comparative analyzes will be carried out blindly
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2024
First Posted
November 14, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
November 14, 2024
Record last verified: 2024-07