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NCT01090713 Clinical Trial

Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

Binge Eating Disorder Clinical Trial

Official title:
Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01090713
Other study ID # LDX in BED
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2010
Last updated July 13, 2016
Start date January 2010
Est. completion date October 2012

Study information
Verified date July 2016
Source Lindner Center of HOPE
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• lisdexamfetamine
oral; 20-70mg/day
• Placebo control
20-70mg; oral

Locations
Country Name City State
United States Lindner Center of HOPE Mason Ohio

Sponsors (3)
Lead Sponsor Collaborator
Lindner Center of HOPE Shire, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary frequency of binge eating episode frequency of binge eating episode 12 weeks Yes
See also
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Completed NCT00330655 - An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder Phase 4
Completed NCT01291173 - Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder Phase 2
Completed NCT03107026 - A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder Phase 3
Completed NCT02079935 - Treatment of Eating Disorders by Physical Activity and Nutrition Counseling N/A
Completed NCT00277641 - Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity Phase 3