Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518941
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 2011 The core salient behavior in AN is maladaptive food restriction that persists even after full weight restoration treatment Steinglass et al 2023 Pharmacologic approaches to the treatment of AN to date have attempted to capitalize on side effect profiles eg weight gain or efficacy in related disorders eg depression but have yielded disappointing results Muratore and Attia 2022 This program of research leverages advances in mechanism research which has identified the importance of habit systems in AN Conceição et al 2023 to test whether a medication can target habitual restrictive intake and thereby help patients with AN
Donepezil is an acetylcholinesterase inhibitor and an FDA-approved medication that has been shown to reverse habitual behaviors like excessive exercise and food restriction in a rodent model of AN Donepezil has been studied for its potential effect in mitigating compulsive habit-like symptoms in other clinical populations with no adverse events Bergman et al 2016 Cubo et al 2008 These data suggest that donepezil may be effective in reducing maladaptive behaviors in compulsive disorders There is no control product in this study
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 25 mg for 2 weeks then 5 mg for 4 weeks The target dose of 5 mgday is lower than the approved dose for dementia and the dose used in a study of adults with Obsessive Compulsive Disorder OCD Bergman et al 2016 Doses may be lowered from those recommended by the protocol if side effects are significant
The primary objective of this study is to test the feasibility and tolerability of donepezil among patients with AN The exploratory objectives are to test the utility of donepezil to modify the habitual behaviors characteristic of AN
Donepezil is an acetylcholinesterase inhibitor and an FDA-approved medication that has been shown to reverse habitual behaviors like excessive exercise and food restriction in a rodent model of AN Donepezil has been studied for its potential effect in mitigating compulsive habit-like symptoms in other clinical populations with no adverse events Bergman et al 2016 Cubo et al 2008 These data suggest that donepezil may be effective in reducing maladaptive behaviors in compulsive disorders There is no control product in this study
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 25 mg for 2 weeks then 5 mg for 4 weeks The target dose of 5 mgday is lower than the approved dose for dementia and the dose used in a study of adults with Obsessive Compulsive Disorder OCD Bergman et al 2016 Doses may be lowered from those recommended by the protocol if side effects are significant
The primary objective of this study is to test the feasibility and tolerability of donepezil among patients with AN The exploratory objectives are to test the utility of donepezil to modify the habitual behaviors characteristic of AN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None