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Original Investigation
September 2017

Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating DisorderA Randomized Clinical Trial

Author Affiliations
  • 1McLean Hospital/Harvard Medical School, Belmont, Massachusetts
  • 2Lindner Center of HOPE, Mason, Ohio
  • 3University of Cincinnati College of Medicine, Cincinnati, Ohio
  • 4At the time of the study, Shire Development LLC, Lexington, Massachusetts
  • 5Now with GlaxoSmithKline, Collegeville, Pennsylvania.
  • 6Now with The Griesser Group, Conshohocken, Pennsylvania
  • 7Now with BTG International, Philadelphia, Pennsylvania.
JAMA Psychiatry. 2017;74(9):903-910. doi:10.1001/jamapsychiatry.2017.1889
Key Points

Question  After initial response to lisdexamfetamine in adults with moderate to severe binge-eating disorder and no other current psychiatric comorbidity, is the relapse risk for binge eating lower with continued lisdexamfetamine treatment compared with placebo?

Findings  In this randomized clinical trial of 418 participants, continued lisdexamfetamine treatment was associated with a significantly lower relapse risk for binge eating over 6 months than placebo (3.7% vs 32.1%). The estimated hazard for relapse with lisdexamfetamine was 11 times lower than with placebo.

Meaning  These findings extend and support previous findings of the efficacy of lisdexamfetamine for the treatment of moderate to severe binge-eating disorder.

Abstract

Importance  The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important.

Objective  To assess lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder.

Design, Setting, and Participants  A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults met DSM-IV-R binge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions−Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase.

Interventions  Lisdexamfetamine administration.

Main Outcomes and Measures  The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events.

Results  Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized lisdexamfetamine responders (placebo, n = 138; lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37; P < .001) for time to relapse; the hazard ratio, based on a Cox proportional hazards model for lisdexamfetamine vs placebo, was 0.09 (95% CI, 0.04-0.23). The treatment-emergent adverse events observed were generally consistent with the known profile of lisdexamfetamine.

Conclusions and Relevance  Risk of binge-eating relapse over 6 months was lower in participants continuing lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with lisdexamfetamine than placebo.

Trial Registration  clinicaltrials.gov Identifier: NCT02009163

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