Treatment with acetylcholine esterase inhibitors in anorexia nervosa : a multicenter double-blind randomised controlled trial versus placebo

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Sainte Anne Paris

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

2 Jul 2025 → ongoing

Decision date (initial)

2024-06-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Evaluate the effect, compared with placebo, of oral administration of donepezil (an acetylcholinesterase inhibitor) on improvement in the symptomatology of anorexia nervosa.

Secondary objectives 3

1. evaluate the effect, compared with placebo, of the administration of acetylcholine esterase inhibitor on weight gain in adult women suffering from anorexia nervosa.
2. evaluate the effect, compared with placebo, of the administration of an acetylcholine esterase inhibitor on habit-forming learning in adult women with AM
3. Evaluate the effect of acetylcholine esterase inhibitor administration on the balance between goal-directed behaviours and habits in adult women with MA

Conditions and MedDRA coding

Anorexia nervosa

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. female
2. Presence of 3 DSM V criteria for anorexia nervosa
3. Restrictive subtype of anorexia nervosa
4. Body Mass Index between 14 and 18.5 kg/m2
5. Aged between 18 and 65
6. Resting heart rate greater than or equal to 40 bpm

Exclusion criteria 10

1. Past diagnosis of anorexia nervosa in the form of hyperphagia/purgation
2. Past diagnosis of bulimia nervosa
3. Past diagnosis of binge eating disorder
4. Comorbid diagnosis of psychotic disorder and/or bipolar disorder
5. Renal impairment (glomerular filtration rate less than 60 mL/min according to the MDRD formula)
6. Liver failure or transaminase elevation greater than 5N
7. Electrocardiogram of conduction disorder
8. Taking a psychotropic drug now or in the three weeks prior to inclusion (including antidepressants, to avoid interaction/potentiation in this population)
9. Taking a treatment involving the following cytochromes : P450, P3A4, P2D6
10. Pregnant or breast-feeding women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Absolute intra-individual difference in the total EDE-Q score obtained between inclusion D0 and D90, i.e. (EDE-Qd90 - EDE-Qd0)

Secondary endpoints 10

1. Intra-individual difference in body mass index between inclusion D0 and D90, and between D0 and D180
2. Difference in intra-individual response rates (rate of responses) in the devalued condition of phase 3 "slip of action" of the HABITS neurocognitive test between D0 and D90.
3. Intra-individual difference in Self-Report Habit Index (SRHI) scores at D0 and D90 (Davis et al IJED 2020).
4. Intra-individual difference between scores at D0 and D90 in the Wisconsin Card Sorting Test (WSCT), Trail Making Test B-A and Brixton test.
5. Intra-individual difference in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores at D0 and D90
6. Evolution of EDE-Q and EDI-3 sub-dimensions scores between inclusion D0 and D90
7. Intra-individual difference in Hospital Anxiety and Depression Scale (HADS) scores between D0 and D90
8. Evolution of the total EDE-Q score between inclusion D0, D90 and D180.
9. Occurrence of adverse events measured according to a standard CTCAE, number of treatment discontinuations due to poor tolerance and changes in biological profile (elevation of transaminases, decrease in PT, prolongation of APTT, increase in CPK, and a disturbance in the blood count formula) performed at D3, D5, D30 and D90
10. Collection and storage of plasma and faeces at D1 and D90

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Sainte Anne Paris

Sponsor organisation

Centre Hospitalier Sainte Anne Paris

Address

1 Rue Cabanis

City

Paris

Postcode

75014

Country

France

Scientific contact point

Organisation

Centre Hospitalier Sainte Anne Paris

Contact name

Khaoussou SYLLA

Public contact point

Organisation

Centre Hospitalier Sainte Anne Paris

Contact name

Khaoussou SYLLA

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications