A Phase 2 interventional study of Donepezil in Anorexia Nervosa, sponsored by New York State Psychiatric Institute. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Other
The purpose of this study is to test the feasibility and tolerability of donepezil in a small group of patients with anorexia nervosa (AN). Study participants will be receiving care at the New York State Psychiatric Institute Eating Disorders Unit. Study medication will be increased from 1 mg per day to a maximum of 5 mg per day for up to 8 weeks. Participants will be closely monitored for side effects by a research psychiatrist every week, in addition to the regular clinical monitoring they receive during inpatient treatment. The study will also include assessments of habit strength to measure any changes in maladaptive eating habits over the course of the treatment.
Anorexia nervosa (AN) is a serious mental illness affecting up to 4% of women in the United States, with a chronic course and a mortality rate 6 times that expected for young women (Arcelus et al., 2011). The core, salient behavior in AN is maladaptive food restriction that persists even after full weight restoration treatment (Steinglass et al., 2023). Pharmacologic approaches to the treatment of AN, to date, have attempted to capitalize on side effect profiles (e.g., weight gain) or efficacy in related disorders (e.g., depression) but have yielded disappointing results (Muratore and Attia, 2022). This program of research leverages advances in mechanism research, which has identified the importance of habit systems in AN (Conceição et al., 2023), to test whether a medication can target habitual restrictive intake and thereby help patients with AN.
Donepezil is an acetylcholinesterase inhibitor and an FDA-approved medication that has been shown to reverse habitual behaviors like excessive exercise and food restriction in a rodent model of AN. Donepezil has been studied for its potential effect in mitigating compulsive, habit-like symptoms in other clinical populations, with no adverse events (Bergman et al., 2016; Cubo et al., 2008). These data suggest that donepezil may be effective in reducing maladaptive behaviors in compulsive disorders. There is no control product in this study.
Study medication will be initiated at 1mg, to be taken before bed. Dosing will follow a flexible titration. The expected titration will be 1 mg for 2 weeks, 2.5 mg for 2 weeks, then 5 mg for 4 weeks. The target dose of 5 mg/day is lower than the approved dose for dementia and the dose used in a study of adults with Obsessive Compulsive Disorder (OCD) (Bergman et al., 2016). Doses may be lowered from those recommended by the protocol if side effects are significant.
The primary objective of this study is to test the feasibility and tolerability of donepezil among patients with AN. The exploratory objectives are to test the utility of donepezil to modify the habitual behaviors characteristic of AN.
Exclusion Criteria:
Donepezil
Drug: Donepezil
Study medication will be initiated at 1mg, to be taken before bed. Dosing will follow a flexible titration. The expected titration will be 1 mg for 2 weeks, 2.5 mg for 2 weeks, then 5 mg for 4 weeks. Doses may be lowered from those recommended by the protocol if side effects are significant.
Side Effects Form
The study psychiatrist will assess the tolerability of donepezil during weekly meetings with participants. The presence of side effects will be assessed using the Side Effects Form. Higher scores indicate more severe side effects (each side effect is scored separately). The Clinical Global Impressions (CGI) scale will evaluate overall functioning and psychopathology.
Time frame: From enrollment to the end of treatment at 8 weeks
Clinical Global Impressions Scale
The Clinical Global Impressions Scale (CGI) is a seven-point scale. A score of 1 indicates the most positive change in the treatment course and the least severity of psychopathology, while a score of 7 indicates the most negative change in the treatment course and the highest severity of psychopathology.
Time frame: From enrollment to the end of treatment at 8 weeks
Self-Report Habit Index
The Self-Report Habit Index (SRHI) is a 12-item scale that measures habit strength. Higher scores indicate greater habit strength.
Time frame: From enrollment to the end of treatment at 8 weeks
Food Choice Task
The Food Choice task is a computer based assessment of preferences for different foods. Higher scores indicate greater preferences. .
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: Undecided — This study aims to include a small number of participants, and privacy and confidentiality will need to be considered against the benefits of data sharing.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute