Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

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

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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