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

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT06518941
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Donepezil — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Open Label
    Donepezil

Primary Outcome Measure

Side Effects Form [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York State Psychiatric InstituteNew YorkNew York10032
Joanna Steinglass, MD
[email protected]
646-774-6345
Joanna Steinglass, MD (PRINCIPAL_INVESTIGATOR)

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