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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Philibert Duriez, MD, PhD contact

0145658345 ext. +33

p.duriez@ghu-paris.fr

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.

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 groups in NCT06687993
Study groupRoleWhat they receive
donepezil 2.5 mgExperimentaldonepezil 2.5 mg daily for 90 days
Receives: Drug: Donepezil 2.5 mg
donepezil 5 mgExperimentaldonepezil 5 mg daily for 90 days
Receives: Drug: Donepezil 5 mg
placeboPlacebo comparatorplacebo 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.

  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)

    Measured: Before (D0) and after 90 days of treatment

Secondary outcomes (10)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted14 Nov 2024
  2. Study startNov 2024 (estimated)
  3. Primary completionFeb 2030 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

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)
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

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.

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