Acetylcholinesterase Inhibitor in Anorexia Nervosa: Multicenter, Double-Blind, Placebo-Controlled Trial
NCT ID: NCT06687993
Last Updated: 2024-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
147 participants
INTERVENTIONAL
2024-11-30
2030-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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donepezil 2.5 mg
donepezil 2.5 mg daily for 90 days
Donepezil 2.5 mg
2.5 mg daily oral intake for 90 days
donepezil 5 mg
donepezil 5 mg daily for 90 days
Donepezil 5 mg
5 mg daily oral intake for 90 days
placebo
placebo daily for 90 days
Placebo Comparator
daily oral intake for 90 days
Interventions
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Donepezil 2.5 mg
2.5 mg daily oral intake for 90 days
Donepezil 5 mg
5 mg daily oral intake for 90 days
Placebo Comparator
daily oral intake for 90 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Université Paris Cité
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Centre Hospitalier St Anne
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2024-511681-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
D22-P020
Identifier Type: -
Identifier Source: org_study_id
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