An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa

Launched by NEW YORK STATE PSYCHIATRIC INSTITUTE · Jul 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called donepezil to see if it can help people with anorexia nervosa, a serious eating disorder. The study will take place at the New York State Psychiatric Institute Eating Disorders Unit and will involve a small group of patients. Participants will start with a low dose of donepezil and gradually increase it over eight weeks. Throughout the study, they will be closely monitored by a psychiatrist to check for any side effects and to assess changes in their eating habits.

To join the study, participants need to be between 18 and 60 years old, have a diagnosis of anorexia nervosa, and have a body mass index (BMI) of at least 15. However, some individuals may not qualify if they have certain health conditions, such as severe mental health issues or specific heart problems. This trial is not yet recruiting participants, but it aims to understand how well donepezil works and how it is tolerated, which means how well people can handle taking the medication.

Gender

ALL

Eligibility criteria

• 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).
• • 4. Bradycardia (below 60 bpm) (vital signs measurement by the clinical team)
• • 5. Corrected QT interval (QTc) greater than 480 ms at baseline (EKG).
• • 6. Antipsychotic medication (antidepressants at a stable dose are allowed) (clinical interview).
• • 7. Known allergic reactions to components of the donepezil (e.g., known hypersensitivity to donepezil hydrochloride) (clinical interview).
• • 8. History of peptic ulcer disease (clinical interview).
• • 9. History of arrhythmia (clinical interview).