Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

This study has been completed.
Sponsor:
Collaborators:
Shire
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

March 19, 2010
October 29, 2012
January 2010
October 2012   (final data collection date for primary outcome measure)
frequency of binge eating episode [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
frequency of binge eating episode
Same as current
Complete list of historical versions of study NCT01090713 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder
Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Binge Eating Disorder
  • Drug: lisdexamfetamine
    oral; 20-70mg/day
  • Drug: Placebo control
    20-70mg; oral
  • Active Comparator: Lisdexamfetamine
    drug
    Intervention: Drug: lisdexamfetamine
  • Placebo Comparator: Placebo
    Placebo comparator
    Intervention: Drug: Placebo control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01090713
LDX in BED
No
Lindner Center of HOPE
Lindner Center of HOPE
  • Shire
  • University of Cincinnati
Not Provided
Lindner Center of HOPE
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP