Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

• Sponsor: Lindner Center of HOPE (Other)
• Overall Status: Completed
• CT.gov ID: NCT01090713
• Collaborator: Shire (Industry), University of Cincinnati (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Binge Eating Disorder	Drug: lisdexamfetamine; Drug: Placebo control	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lisdexamfetamine drug	Drug: lisdexamfetamine; oral; 20-70mg/day
Placebo Comparator: Placebo Placebo comparator	Drug: Placebo control; 20-70mg; oral

Outcome Measures

Primary Outcome Measures

1. frequency of binge eating episode [12 weeks]

   frequency of binge eating episode

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Lindner Center of HOPE	Mason	Ohio	United States	45040

Sponsors and Collaborators

• Lindner Center of HOPE
• Shire
• University of Cincinnati

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lindner Center of HOPE
• ClinicalTrials.gov Identifier: NCT01090713
• Other Study ID Numbers: LDX in BED
• First Posted: Mar 22, 2010
• Last Update Posted: Jul 15, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Lisdexamfetamine Dimesylate

Study Results

No Results Posted as of Jul 15, 2016