Status:
NOT_YET_RECRUITING
An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 St...
Detailed 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., 20...
Eligibility Criteria
Inclusion
- 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
- 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).
- Antipsychotic medication (antidepressants at a stable dose are allowed) (clinical interview).
- Known allergic reactions to components of the donepezil (e.g., known hypersensitivity to donepezil hydrochloride) (clinical interview).
- History of peptic ulcer disease (clinical interview).
- History of arrhythmia (clinical interview).
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06518941
Start Date
June 1 2026
End Date
December 1 2027
Last Update
July 14 2025
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032