Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder

被引:0
作者
Guerdjikova, Anna I. [1 ,2 ]
Romo-Nava, Francisco [1 ,2 ]
Blom, Thomas J. [1 ,2 ]
Mori, Nicole [1 ,2 ]
McElroy, Susan L. [1 ,2 ]
机构
[1] Lindner Ctr HOPE, 4075 Old Western Row Rd, Mason, OH 45040 USA
[2] Univ Cincinnati, Coll Med, Dept Psychiat & Behav Neurosci, Stetson Bldg,260 Stetson St,Suite 3200, Cincinnati, OH 45219 USA
关键词
Binge eating disorder; Solriamfetol; Randomized controlled trial; ADULTS; LISDEXAMFETAMINE; EFFICACY; MODERATE; SAFETY;
D O I
10.1016/j.cct.2021.106587
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Introduction: Binge eating disorder (BED) is an important public health problem associated with severe psychosocial and medical consequences for which treatment options are limited. The objective of this study is to evaluate the efficacy and tolerability of the novel dopamine and norepinephrine reuptake inhibitor (DNRI) solriamfetol in the treatment of BED. Methods: This study is a 12-week, randomized (1:1 ratio), placebo-controlled, double-blind, parallel-group, 2-arm clinical trial of solriamfetol in 64 outpatients with BED. The primary outcome is binge-eating day frequency as assessed by take-home patient-completed binge eating diaries. Secondary outcomes include binge-eating episode frequency and scores on The Yale-Brown Obsessive Compulsive Scale for Binge Eating (YBOCS-BE) and Clinical Global Severity (CGI-S) scale. Discussion: To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of solriamfetol in BED. We highlight the background and rationale for this study, including a discussion on using DNRIs in BED.
引用
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页数:6
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