The goal of this project is to evaluate the efficacy and tolerability of the novel dopamine and norepinephrine reuptake inhibitor (DNRI) solriamfetol in the treatment of binge eating disorder (BED).
This is a 1-site, randomized, parallel group, double-blind, placebo-controlled, flexible-dose study in which solriamfetol 37.5-150 mg/day will be administered for 12 weeks to 64 outpatient adults with BED by DSM-5 criteria. The study will have 3 phases: a 1-2 week Screening phase to evaluate participant eligibility; a 12-week blinded Treatment phase during which participants will receive solriamfetol or matching placebo; and a 1-week Treatment Discontinuation phase. During the Treatment phase, participants will be evaluated weekly for the first 4 weeks and then biweekly for the next 8 weeks. Solriamfetol will be started at 37.5 mg/day. After 1 week, study drug will be increased to 75 mg/day. If a participant continues to have BED symptoms, study drug may be increased to a maximum of 150 mg/d by Treatment week 6; after that, study drug dose will be held constant. Efficacy will be assessed by measuring the weekly frequency of binge-eating episode days with patient take-home diaries. Regular monitoring of vital signs, laboratory tests, electrocardiograms (ECGs), adverse events, and suicidality will assess safety
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Solriamfetol is a novel DNRI (novel dopamine and norepinephrine reuptake inhibitor) that has recently received regulatory approval for the treatment of excessive daytime sleepiness in individuals with narcolepsy or obstructive sleep apnea.
A placebo is a substance or treatment which is designed to have no therapeutic value (an inactive compound, i.e. inert, often called a "sugar pill").
Lindner Center of HOPE
Mason, Ohio, United States
RECRUITINGThe primary efficacy variable is binge-eating day frequency as assessed by the take-home patient diary.
days with binge eating episodes
Time frame: Days 1-84
The secondary efficacy variables will include binge-eating episode frequency.
Number of binge eating episodes per week
Time frame: Days 1-84
The score on the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOC-BE).
Questions on scale range from 0-4, higher scores are worse. There are 10 questions total. The first 5 questions consist of the "obsessional sub-total" (scores are added together). Questions 6-10 are added together and equal the "compulsion sub-total."
Time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12
The score on the Clinical Global Impression-Severity (CGI-S) and Clinical Global Impressions-Improvement scale (CGI-I).
The Clinical Global Impression - Severity and Improvement scale (CGI-S, CGI-I) is a 7-point scale that requires the clinician to rate the severity and improvement of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. On the CGI-S question, scores range from 1-7, with higher scores being worse (1 = normal, 7 = very severely ill). On the CGI-I questions, scores range from 1-8, with higher scores being worse (1 = no change, 7 = very much worse, 8 = not applicable).
Time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12
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