Contemporary clinical trials · 2021
Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder.
Протокол клинического исследованияСтатьяПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Guerdjikova Anna I, Romo-Nava Francisco, Blom Thomas J, Mori Nicole, McElroy Susan L
Аннотация
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 (CGIS) 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.
TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov, identifier NCT04602936, on Oct 26, 2020 https://www.clinicaltrials.gov/ct2/show/NCT04602936.
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 (CGIS) 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.
TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov, identifier NCT04602936, on Oct 26, 2020 https://www.clinicaltrials.gov/ct2/show/NCT04602936.