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Trial record 2 of 7 for:    Lisdexamfetamine binge eating

Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

This study has been completed.
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE Identifier:
First received: March 19, 2010
Last updated: July 13, 2016
Last verified: July 2016
The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine compared with placebo in outpatients with binge eating disorder

Condition Intervention Phase
Binge Eating Disorder
Drug: lisdexamfetamine
Drug: Placebo control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity

Resource links provided by NLM:

Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • frequency of binge eating episode [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    frequency of binge eating episode

Enrollment: 50
Study Start Date: January 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lisdexamfetamine
Drug: lisdexamfetamine
oral; 20-70mg/day
Placebo Comparator: Placebo
Placebo comparator
Drug: Placebo control
20-70mg; oral


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01090713

United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Lindner Center of HOPE
University of Cincinnati
  More Information

Responsible Party: Lindner Center of HOPE Identifier: NCT01090713     History of Changes
Other Study ID Numbers: LDX in BED 
Study First Received: March 19, 2010
Last Updated: July 13, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Feeding and Eating Disorders
Binge-Eating Disorder
Lisdexamfetamine Dimesylate
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents processed this record on October 27, 2016