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Completed

NCT Number: NCT01090713

Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

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

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Key information

Conditions

Binge Eating Disorder Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Lisdexamfetamine

Drug

oral; 20-70mg/day

Placebo Control

Drug

20-70mg; oral

Primary outcomes

  1. frequency of binge eating episode

    Time frame: 12 weeks

    frequency of binge eating episode

Sponsors and collaborators

Lead sponsor

Lindner Center of HOPE

Other

Collaborators

  • Shire
  • University of Cincinnati

Registry information

Official study title

Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 22, 2010
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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