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.
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study (Clinical interview).
Aged 18-60 years (Clinical interview).
Diagnosed with anorexia nervosa (EDA-5).
Score of High Risk on the Columbia Suicide Severity Scale (C-SSRS).
Pregnancy (Serum pregnancy test on admission).
Current diagnosis of schizophrenia, schizophreniform disorder, bipolar (type I), or substance use disorder (SCID).
Bradycardia (below 60 bpm) (vital signs measurement by the clinical team)
Single group
Donepezil
DrugStudy 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.
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.
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.
Food Choice Task
The Food Choice task is a computer based assessment of preferences for different foods. Higher scores indicate greater preferences. .
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