Donepezil for Anorexia

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: New York State Psychiatric Institute

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with anorexia nervosa receiving care at the New York State Psychiatric Institute Eating Disorders Unit. Participants will be given donepezil, starting at 1 mg per day and potentially increasing to 5 mg daily over 8 weeks.

Inclusion Criteria

Provision of signed and dated informed consent form

I am willing and able to follow all study requirements.

I am between 18 and 60 years old.

Exclusion Criteria

I have a history of irregular heartbeats.

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)

Treatment Details

Interventions

• Donepezil (Cholinesterase Inhibitor)

Trial Overview The study aims to test the feasibility and tolerability of donepezil in patients with anorexia nervosa. The medication dosage may increase gradually, and changes in maladaptive eating habits will be monitored throughout the treatment.

Participant Groups

Group I: Open Label Experimental Treatment 1 Intervention

Donepezil

Donepezil is already approved in Canada, Japan for the following indications:

Approved in Canada as Aricept for:

• Alzheimer's disease

Approved in Japan as Aricept for:

• Alzheimer's disease

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+