Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder.
Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder.
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solriamfetol 治疗暴食症的随机、安慰剂对照试验的研究方案和基本原理。
DOI：
10.1016/j.cct.2021.106587
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发表时间：
2021
影响因子：
2.2
通讯作者：
McElroy,SusanL
中科院分区：
文献类型：
--
作者：
Guerdjikova,AnnaI;Romo-Nava,Francisco;Blom,ThomasJ;Mori,Nicole;McElroy,SusanL
暴食症（BED）是一个重要的公共卫生问题，与严重的心理社会和医疗后果，治疗方案是有限的。本研究的目的是评估新的多巴胺和去甲肾上腺素再摄取抑制剂（DNRI）solriamfetol在治疗BED.MethodsThis研究的疗效和耐受性是一个12周，随机（1：1的比例），安慰剂对照，双盲，平行组，2臂临床试验solriamfetol在64个门诊患者与BED。主要结果是通过带回家的患者完成的暴饮暴食日记评估的暴饮暴食日频率。次要结果包括暴饮暴食发作频率和耶鲁-布朗强迫症量表暴饮暴食（YBOCS-BE）和临床全球严重程度（CGI single bondS）scale.DiscussionTo我们所知，这是第一个随机，双盲协议调查solriamfetol在床上的安全性和有效性。我们强调了这项研究的背景和基本原理，包括关于在BED中使用DNRI的讨论。试验注册这项研究于2020年10月26日在https://www.clinicaltrials.gov/ct2/show/NCT04602936上注册，标识符NCT 04602936。ClinicalTrials.gov
IntroductionBinge 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.MethodsThis 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 (CGIsingle bondS) scale.DiscussionTo 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.Trial registrationThis study was registered on ClinicalTrials.gov, identifier NCT04602936, on Oct 26, 2020 https://www.clinicaltrials.gov/ct2/show/NCT04602936.