• Login
    View Item 
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2019
    • View Item
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2019
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of UMB Digital ArchiveCommunitiesPublication DateAuthorsTitlesSubjectsThis CollectionPublication DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    Display statistics

    An Innovative Disease-Drug-Trial Framework to Guide Binge Eating Disorder Drug Development: A Case Study for Topiramate

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Author
    Kalaria, S.N.
    Gobburu, J.
    Gopalakrishnan, M.
    Date
    2019
    Journal
    Clinical and Translational Science
    Publisher
    Blackwell Publishing Ltd
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1111/cts.12682
    Abstract
    As with other psychiatric disorders, development of drugs to treat binge-eating disorder (BED) has been hampered by high placebo response and dropout rates in randomized controlled trials (RCTs). Although not approved for use in BED, several RCTs have suggested that topiramate is efficacious for BED in obese individuals. Using data from a positive investigator-initiated RCT of topiramate in 61 obese individuals with BED, the objective of the present study is (i) to develop a quantitative disease-drug-trial framework to inform future BED clinical trial designs, and (ii) to determine the optimal topiramate dose to achieve therapeutic efficacy. Disease-drug-trial models were developed separately for the two efficacy measures, namely, longitudinal normalized weekly binge-eating episode frequency (BEF) and binge day frequency (BDF). Model building consisted of (i) developing a placebo effect model that describes response from the placebo group, (ii) adding a drug effect to the placebo model to describe dose-response relationships, and (iii) developing a parametric time to event model to characterize patient dropout patterns. The placebo effect on normalized BEF and BDF over time demonstrated a maximum decrease of ~ 57% by 5 weeks. Participants had a higher dropout probability if no weight loss occurred during the trial period. The identified dose-response relationship demonstrated a daily dose of 125 mg was needed to exhibit a marked reduction in weekly BEF. The developed comprehensive disease-drug-trial model will be utilized to simulate different clinical trial designs to increase the success for future BED drug development programs. Copyright 2019 The Authors.
    Keyword
    Binge-Eating Disorder
    Drug Development
    Randomized Controlled Trials as Topic
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85071951672&doi=10.1111%2fcts.12682&partnerID=40&md5=831e31479a502f7360104eea18babb26; http://hdl.handle.net/10713/10860
    ae974a485f413a2113503eed53cd6c53
    10.1111/cts.12682
    Scopus Count
    Collections
    UMB Open Access Articles 2019

    entitlement

    Related articles

    • A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa.
    • Authors: Safer DL, Adler S, Dalai SS, Bentley JP, Toyama H, Pajarito S, Najarian T
    • Issue date: 2020 Feb
    • Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa.
    • Authors: Dalai SS, Adler S, Najarian T, Safer DL
    • Issue date: 2018 Jan
    • Double-blind, randomized, placebo-controlled trial of topiramate plus cognitive-behavior therapy in binge-eating disorder.
    • Authors: Claudino AM, de Oliveira IR, Appolinario JC, Cordás TA, Duchesne M, Sichieri R, Bacaltchuk J
    • Issue date: 2007 Sep
    • Topiramate in the treatment of binge eating disorder associated with obesity: a randomized, placebo-controlled trial.
    • Authors: McElroy SL, Arnold LM, Shapira NA, Keck PE Jr, Rosenthal NR, Karim MR, Kamin M, Hudson JI
    • Issue date: 2003 Feb
    • Orlistat with behavioral weight loss for obesity with versus without binge eating disorder: randomized placebo-controlled trial at a community mental health center serving educationally and economically disadvantaged Latino/as.
    • Authors: Grilo CM, White MA
    • Issue date: 2013 Mar
    DSpace software (copyright © 2002 - 2021)  DuraSpace
    Quick Guide | Policies | Contact Us | UMB Health Sciences & Human Services Library
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.