Anorexia Nervosa Restricting TypePhase 2ANAChNCT06687993
Acetylcholinesterase Inhibitor in Anorexia Nervosa: Multicenter, Double-Blind, Placebo-Controlled Trial
A Phase 2 study testing Donepezil 2.5 mg and Donepezil 5 mg in people with Anorexia Nervosa Restricting Type, run by Centre Hospitalier St Anne.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anorexia Nervosa Restricting Type
- What is being tested?
- Donepezil 2.5 mg and Donepezil 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Use of a highly effective contraceptive method
- Affiliation or entitlement to a Health Insurance scheme
- Prior free, informed, and written consent
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acetylcholinesterase Inhibitor Treatment in Anorexia Nervosa: a Multicenter, Double-Blind, Placebo-Controlled Randomized Trial
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.
- Conditions
- Anorexia Nervosa Restricting Type
- Being tested
- Donepezil 2.5 mg, Donepezil 5 mg, Placebo Comparator
- Keywords
- anorexia nervosa, eating disorders, donepezil, habits
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil 2.5 mgDrug
Also called Donepezil chlorhydrate
2.5 mg daily oral intake for 90 days
Donepezil 5 mgDrug
Also called Donepezil chlorhydrate
5 mg daily oral intake for 90 days
Placebo ComparatorDrug
Also called Placebo
daily oral intake for 90 days
| Study group | Role | What they receive |
|---|---|---|
| donepezil 2.5 mg | Experimental | donepezil 2.5 mg daily for 90 days Receives: Drug: Donepezil 2.5 mg |
| donepezil 5 mg | Experimental | donepezil 5 mg daily for 90 days Receives: Drug: Donepezil 5 mg |
| placebo | Placebo comparator | placebo daily for 90 days Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
The Trail Making Test (TMT) is used to assess cognitive processing speed, flexibility, and task-switching abilities. TMT B-A represents the difference in time taken to complete Part B (which involves both numbers and letters) compared to Part A (numbers only).
Scale Range: The B-A score is expressed in seconds, typically ranging from 0 to several hundred seconds depending on the individual's performance.
Score Interpretation: Higher scores indicate slower processing and greater difficulty with task switching, representing a worse outcome for cognitive flexibility and processing speed.
Measured: 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
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a clinician-administered tool used to assess the severity of obsessive-compulsive symptoms, measuring both obsessions and compulsions.
Scale Range: The total score ranges from 0 to 40, with subscales for obsessions and compulsions each ranging from 0 to 20.
Score Interpretation: Higher scores indicate greater severity of OCD symptoms. Thus, a higher total score reflects a worse outcome in terms of obsessive-compulsive symptom severity.
Measured: 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
Eating Disorder Inventory-3 (EDI-3) Subdimensions The EDI-3 measures psychological traits associated with eating disorders through 12 subscales, including Drive for Thinness, Bulimia, Body Dissatisfaction, Low Self-Esteem, Personal Alienation, Interpersonal Insecurity, Interpersonal Alienation, Interoceptive Deficits, Emotional Dysregulation, Perfectionism, Asceticism, and Maturity Fears.
Scale Range: Each subscale has a score range of 0 to 16, though the maximum score can vary slightly depending on the specific items within each subscale.
Score Interpretation: Higher scores indicate greater severity of the particular trait or symptom associated with eating disorders. Therefore, higher scores across subscales reflect a worse outcome regarding eating disorder psychopathology.
Measured: 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)
The Hospital Anxiety and Depression Scale (HADS) is a self-report measure designed to assess levels of anxiety and depression in patients, particularly in hospital settings. The scale consists of two subscales: Anxiety (HADS-A) and Depression (HADS-D).
Scale Range: Each subscale (HADS-A and HADS-D) has a score range from 0 to 21, with the total score ranging from 0 to 42.
Score Interpretation: Higher scores indicate more severe symptoms of anxiety or depression. Thus, higher scores on each subscale, or the total score, represent worse outcomes in terms of anxiety and depression severity.
Measured: Before (D0) and after 90 days of treatment
Measure the toxicity and tolerance of donepezil in adult women suffering from anorexia nervosa
Difference of frequency of adverse effects
Measured: D3, D5, D30, D90
Biological factors associated with response to treatment
Gut microbiome diversity (Simpson, Shannon and Chao1) and nutritional plasmatic biomarkers
Measured: Before (D0) and after 90 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia Nervosa Restricting TypeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Multicenter, superiority study, in double-blind, randomized, parallel groups, controlled versus placebo, in using a sequential adaptive design by band.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Université Paris Cité, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687993
- Sponsor's protocol ID
- D22-P020
- Other IDs
- 2024-511681-37-00
- Acronym
- ANACh
- Status last verified
- Jul 2024
- First submitted
- 30 Sep 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetylcholinesterase Inhibitor Treatment in Anorexia Nervosa: a Multicenter, Double-Blind, Placebo-Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT06687993
- Acronym / sponsor ID
- ANACh / D22-P020
- Conditions
- Anorexia Nervosa Restricting Type
- Keywords
- anorexia nervosa, eating disorders, donepezil, habits
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Université Paris Cité, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Nov 2024 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Multicenter, superiority study, in double-blind, randomized, parallel groups, controlled versus placebo, in using a sequential adaptive design by band.
| Arm | Type | Receives |
|---|---|---|
| donepezil 2.5 mg | Experimental | Drug: Donepezil 2.5 mgdonepezil 2.5 mg daily for 90 days |
| donepezil 5 mg | Experimental | Drug: Donepezil 5 mgdonepezil 5 mg daily for 90 days |
| placebo | Placebo comparator | Drug: Placebo Comparatorplacebo daily for 90 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil 2.5 mgAlso: Donepezil chlorhydrate2.5 mg daily oral intake for 90 days | Drug | donepezil 2.5 mg |
| Donepezil 5 mgAlso: Donepezil chlorhydrate5 mg daily oral intake for 90 days | Drug | donepezil 5 mg |
| Placebo ComparatorAlso: Placebodaily oral intake for 90 days | Drug | placebo |
Primary outcome
Effect on Body Mass Index in adult women suffering from anorexia nervosa
Time frame: Before (D0) and after 90 days of treatment
Difference of Body Masse Index between inclusion (D0) and the end of treatment (D90)
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil 2.5 mg and Donepezil 5 mg in people with Anorexia Nervosa Restricting Type, run by Centre Hospitalier St Anne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philibert Duriez, MD, PhD (0145658345 ext. +33, p.duriez@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on Body Mass Index in adult women suffering from anorexia nervosa (time frame: Before (D0) and after 90 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.