Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

Phase 3

Completed

• Conditions: Binge Eating Disorder
• Interventions: Drug: lisdexamfetamine; Drug: Placebo control

• Registration Number: NCT01090713
• Lead Sponsor: Lindner Center of HOPE

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-22
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lisdexamfetamine	lisdexamfetamine	drug
Placebo	Placebo control	Placebo comparator

Primary Outcome Measures

Name	Time	Method
frequency of binge eating episode	12 weeks	frequency of binge eating episode

Trial Locations

Locations (1)

Lindner Center of HOPE; 🇺🇸 Mason, Ohio, United States