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.
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
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
Sequential
Donepezil 2.5 mg
Drug2.5 mg daily oral intake for 90 days
Donepezil 5 mg
Drug5 mg daily oral intake for 90 days
Placebo Comparator
Drugdaily oral intake for 90 days
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)
Effect on eating disorder symptomatology in adult women suffering from anorexia nervosa: difference of Eating Disorder Examination Questionnaire (EDE-Q) score
The Eating Disorder Examination Questionnaire (EDE-Q) is a self-report measure used to assess the severity of eating disorder symptoms. The scale consists of four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern, along with a Global score. Scale Range: Each subscale score and the Global score range from 0 to 6. Score Interpretation: Higher scores indicate greater severity of eating disorder symptoms. A higher score reflects a worse outcome in terms of eating disorder symptom severity.
Effects on habits learning in adult women suffering from anorexia nervosa: difference of phase 3 of slips-of-action neurocognitive test
The Slips-of-Action Neurocognitive Test is a measure designed to assess cognitive control, focusing on the ability to inhibit responses that are no longer contextually appropriate. In Phase 3 of this test, participants must withhold previously learned responses as the rules change, evaluating their inhibitory control capacity. Scale Range: Scores in Phase 3 range from 0 to 20, representing the number of errors (or "slips") made during the test. Score Interpretation: Higher scores reflect a greater number of inhibitory errors, indicating reduced cognitive control. Thus, a higher score represents a worse outcome in terms of inhibitory control performance.
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
The Self-Report Habit Index (SRHI) is a tool used to measure the strength of habitual behaviors. It assesses habits across various domains, providing a total score that reflects the extent to which a behavior has become automatic. Scale Range: The total score ranges from 0 to 42, with higher scores indicating stronger habitual behavior. Score Interpretation: A higher score suggests a more entrenched habit, reflecting a stronger habitual response. Thus, higher scores indicate a worse outcome if the goal is to reduce the habitual behavior.
Effect on cognitive flexibility in adult women suffering from anorexia nervosa: difference in Wisconsin Card Sorting Test
The Wisconsin Card Sorting Test (WCST) assesses cognitive flexibility and executive function by measuring an individual's ability to adapt to changing rules and shift cognitive strategies. Scale Range: Scores are typically reported as the number of perseverative errors, ranging from 0 to a maximum depending on the number of trials (typically 128). Score Interpretation: Higher scores indicate more errors and reflect poorer cognitive flexibility. Therefore, a higher score represents a worse outcome in terms of executive functioning.
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Centre Hospitalier St Anne
Lead sponsor
Université Paris Cité
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
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