Evidence map›Paper›PMID 26346638›Full record

Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2016

Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials.

Susan L McElroy, James Hudson, M Celeste Ferreira-Cornwell, Jana Radewonuk, Timothy Whitaker, Maria Gasior

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 73 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 4 pooled it
21.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01718483 phase3completednot on this map

The SPD489-343, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

TypeinterventionalSponsorShireRan2012 to 2013Enrolled383ConditionsBinge Eating DisorderArmsSPD489 (Lisdexamfetamine dimesylate), Placebo
NCT01718509 phase3completednot on this map

The SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

TypeinterventionalSponsorShireRan2012 to 2013Enrolled390ConditionsBinge Eating DisorderArmsSPD489 (Lisdexamfetamine dimesylate), Placebo
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 4 syntheses or guidelines pooled it, 253 citations in OpenAlex.

  1. Pooled it
  2. Effect of amphetamines on blood pressure.The Cochrane database of systematic reviews · 2025
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  17. A psychometric analysis and revalidation of the Yale-Brown Obsessive Compulsive Scale modified for Binge Eating in adults with binge eating disorder.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2019
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13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Susan L McElroyLindner Center of HOPE, Mason, OH, USA.
James HudsonBiological Psychiatry Laboratory, McLean Hospital, Belmont, MA, USA.
M Celeste Ferreira-CornwellGlobal Clinical Development, Shire, Wayne, PA, USA.
Jana RadewonukClinical Development Operations & Biometrics, Shire, Wayne, PA, USA.
Timothy WhitakerGlobal Clinical Development, Shire, Wayne, PA, USA.
Maria GasiorGlobal Clinical Development, Shire, Wayne, PA, USA.
Center for Global Development · USTakeda (United States) · USHarvard University · USUniversity of Cincinnati Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The efficacy and safety of lisdexamfetamine dimesylate (LDX) vs placebo in binge eating disorder (BED) was evaluated in two multicenter, double-blind, placebo-controlled trials. Adults (study 1, n=383; study 2, n=390) meeting DSM-IV-TR BED criteria were randomized (1:1) to placebo or LDX (50 or 70 mg/day) dose titration; optimized doses were maintained to the end of double-blind treatment (week 12/early termination). Change from baseline in binge eating days/week at weeks 11-12 (primary efficacy endpoint) was assessed with mixed-effects models for repeated measures. Secondary endpoints related to binge eating and medical parameters, safety, and treatment compliance were also assessed. Least squares mean (95% CI) treatment differences for change from baseline binge eating days/week at weeks 11-12 significantly favored LDX (study 1: -1.35 [-1.70, -1.01]; study 2: -1.66 [-2.04, -1.28]; both P<0.001). In both studies, treatment-emergent adverse events (TEAEs) reported by ⩾10% of LDX participants were dry mouth, insomnia, and headache. Serious TEAEs occurred in two (1.1%) placebo participants in each study and in three (1.6%) and one (0.6%) LDX participants in study 1 and study 2, respectively. Across studies, mean increases from baseline at week 12/early termination with LDX for pulse and systolic and diastolic blood pressure ranged from 4.41-6.31 b.p.m. and 0.2-1.45 and 1.06-1.83 mm Hg, respectively. LDX (50 and 70 mg/day) was superior to placebo in decreasing binge eating days/week from baseline and improving binge eating-related key secondary endpoints. Safety results appear consistent with the known safety profile of LDX.

Indexed as

AdultBinge-Eating DisorderDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansLisdexamfetamine DimesylateMaleTreatment OutcomeLisdexamfetamine Dimesylate

Identifiers

PMID26346638
PMCPMC4793109
OpenAlexW1425537810

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.