An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa
New York State Psychiatric Institute
Summary
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.
Description
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, 2…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study (Clinical interview). 3. Aged 18-60 years (Clinical interview). 4. Diagnosed with anorexia nervosa (EDA-5). 5. BMI ≥ 15 kg/m2 (Clinical team medical record) Exclusion Criteria: 1. Score of High Risk on the Columbia Suicide Severity Scale (C-SSRS). 2. Pregnancy (Serum pregnancy test on admission). 3. Current diagnosis of schizophrenia, schizophreniform disorder, bipolar (type I), or substance use disorder (SCID).…
Interventions
- DrugDonepezil
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.
Location
- New York State Psychiatric InstituteNew York, New York