search
Back to results

Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

Primary Purpose

Binge Eating Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lisdexamfetamine
Placebo control
Sponsored by
Lindner Center of HOPE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lindner Center of HOPE

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lisdexamfetamine

Placebo

Arm Description

drug

Placebo comparator

Outcomes

Primary Outcome Measures

frequency of binge eating episode
frequency of binge eating episode

Secondary Outcome Measures

Full Information

First Posted
March 19, 2010
Last Updated
July 13, 2016
Sponsor
Lindner Center of HOPE
Collaborators
Shire, University of Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT01090713
Brief Title
Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder
Official Title
Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lindner Center of HOPE
Collaborators
Shire, University of Cincinnati

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lisdexamfetamine
Arm Type
Active Comparator
Arm Description
drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
lisdexamfetamine
Intervention Description
oral; 20-70mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo control
Intervention Description
20-70mg; oral
Primary Outcome Measure Information:
Title
frequency of binge eating episode
Description
frequency of binge eating episode
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Lindner Center of HOPE
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

We'll reach out to this number within 24 hrs