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CompletedNCT01090713Updated Jul 15, 2016

Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

A Phase 3 interventional study of lisdexamfetamine and Placebo control in Binge Eating Disorder, sponsored by Lindner Center of HOPE. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-15.

Sponsored by Lindner Center of HOPE · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine compared with placebo in outpatients with binge eating disorder

02

Conditions studied

03

In context

Bulimia

319 studies on the registry are indexed under Bulimia; 53 are open to participants now.

This study's enrollment of 50 is below the median of 61 across 249 interventional studies indexed under Bulimia.

Browse Bulimia studies →

Lead sponsor

Lindner Center of HOPE is the lead sponsor of 26 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients will meet DSM-IV criteria for BED for at least the last 6 months

Exclusion criteria

Exclusion Criteria:

  • Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. If there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (All women of childbearing potential will have a negative pregnancy test before entering the study.)
  • Subjects who are displaying clinically significant suicidality or homicidality.
  • A current or recent (within 6 months of the start of study medication) DSM-IV diagnosis of substance abuse or dependence
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Lisdexamfetamine

    drug

    Drug: lisdexamfetamine

  • Placebo comparator
    Placebo

    Placebo comparator

    Drug: Placebo control

Interventions

  • Druglisdexamfetamine

    oral; 20-70mg/day

  • DrugPlacebo control

    20-70mg; oral

06

What researchers measure

Primary outcomes

  1. frequency of binge eating episode

    frequency of binge eating episode

    Time frame: 12 weeks

07

Study locations

1 site
  • Lindner Center of HOPE
    Mason, Ohio 45040, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01090713
Lead sponsor
Lindner Center of HOPE
Collaborators
Shire, University of Cincinnati
Responsible party
Sponsor
First posted
Mar 22, 2010
Start date
Jan 2010
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Jul 15, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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