Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

NCT ID: NCT01090713

Last Updated: 2016-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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Conditions

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Binge Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lisdexamfetamine

drug

Group Type ACTIVE_COMPARATOR

lisdexamfetamine

Intervention Type DRUG

oral; 20-70mg/day

Placebo

Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DRUG

20-70mg; oral

Interventions

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lisdexamfetamine

oral; 20-70mg/day

Intervention Type DRUG

Placebo control

20-70mg; oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shire

INDUSTRY

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

Lindner Center of HOPE

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lindner Center of HOPE

Mason, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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LDX in BED

Identifier Type: -

Identifier Source: org_study_id

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