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Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

This study has been completed.
Sponsor:
Collaborators:
Shire Development LLC
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT01090713
First received: March 19, 2010
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • frequency of binge eating episode [ Time Frame: 24 months ] [ 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
 Drug: lisdexamfetamine
oral; 20-70mg/day
Placebo Comparator: Placebo
Placebo comparator
 Drug: Placebo control
20-70mg; oral

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090713

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

No publications provided

Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT01090713     History of Changes
Other Study ID Numbers: LDX in BED
Study First Received: March 19, 2010
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Dextroamphetamine
Dopamine Uptake Inhibitors
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013