An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa (NCT06518941) | Clinical Trial Compass
Not Yet RecruitingPhase 2
An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa
United States10 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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).
✓. BMI ≥ 15 kg/m2 (Clinical team medical record)
Exclusion criteria
✕. 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)
✕. Corrected QT interval (QTc) greater than 480 ms at baseline (EKG).
What they're measuring
1
Side Effects Form
Timeframe: From enrollment to the end of treatment at 8 weeks
2
Clinical Global Impressions Scale
Timeframe: From enrollment to the end of treatment at 8 weeks