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Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

L

Lindner Center of HOPE

Status and phase

Completed
Phase 3

Conditions

Binge Eating Disorder

Treatments

Drug: lisdexamfetamine
Drug: Placebo control

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01090713
LDX in BED

Details and patient eligibility

About

The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine compared with placebo in outpatients with binge eating disorder

Enrollment

50 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups, including a placebo group

Lisdexamfetamine
Active Comparator group
Description:
drug
Treatment:
Drug: lisdexamfetamine
Placebo
Placebo Comparator group
Description:
Placebo comparator
Treatment:
Drug: Placebo control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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