NCT01090713

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

2.8 years

First QC Date

March 19, 2010

Last Update Submit

July 13, 2016

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

  • frequency of binge eating episode

    frequency of binge eating episode

    12 weeks

Study Arms (2)

Lisdexamfetamine

ACTIVE COMPARATOR

drug

Drug: lisdexamfetamine

Placebo

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo control

Interventions

lisdexamfetamineDRUG

oral; 20-70mg/day

Lisdexamfetamine
Placebo controlDRUG

20-70mg; oral

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients will meet DSM-IV criteria for BED for at least the last 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2010

First Posted

March 22, 2010

Study Start

January 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

July 15, 2016

Record last verified: 2016-07

Locations

US(1)