Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01090713

Enrollment

Registered

2010-03-22

Start date

2010-01-31

Completion date

2012-10-31

Last updated

2016-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder

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

Interventions

DRUGlisdexamfetamine

oral; 20-70mg/day

DRUGPlacebo control

20-70mg; oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
frequency of binge eating episode	12 weeks	frequency of binge eating episode

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026