Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
NCT ID: NCT01291173
Last Updated: 2021-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
271 participants
INTERVENTIONAL
2011-05-10
2012-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SPD489 30 mg
lisdexamfetamine dimesylate (SPD489)
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50 mg
lisdexamfetamine dimesylate (SPD489)
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70 mg
lisdexamfetamine dimesylate (SPD489)
SPD489 70mg capsule taken once-daily for up to 11 weeks
Placebo
Placebo
Placebo capsule taken once daily for up to 11 weeks
Interventions
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lisdexamfetamine dimesylate (SPD489)
SPD489-30mg capsules taken once daily for up to 11 weeks
lisdexamfetamine dimesylate (SPD489)
SPD489 50mg capsules taken once-daily for up to 11 weeks
lisdexamfetamine dimesylate (SPD489)
SPD489 70mg capsule taken once-daily for up to 11 weeks
Placebo
Placebo capsule taken once daily for up to 11 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Binge eating disorder is of at least moderate severity in which subjects report at least 3 binge eating days per week.
* Subject has a body mass index (BMI) of \>24 and \<46.
Exclusion
* Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
* Subject is considered a suicide risk or risk to harm others.
18 Years
55 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Southwestern Research, Inc.
Beverly Hills, California, United States
Scripps Clinical Research Services
La Jolla, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
PCSD - Feighner Research
San Diego, California, United States
Florida Clinical Research
Bradenton, Florida, United States
Gulfcoast Clinical Research
Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Vince and Assoc. Research
Overland Park, Kansas, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States
Marc Hertzman, MD, PC
Rockville, Maryland, United States
McLean Hospital
Belmont, Massachusetts, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Unniversity of Minnesota
Minneapolis, Minnesota, United States
Weight Disorders Washington University School of Medicine, Dept of Psychiatry
St Louis, Missouri, United States
Robert Lynn Horne, MD
Las Vegas, Nevada, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Neuropsychiatric Research Institute
Fargo, North Dakota, United States
Community Research
Cincinnati, Ohio, United States
Lindner City of Hope
Mason, Ohio, United States
Weight Management Center, Medical University of South Carolina
Charleston, South Carolina, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Clinical Trials
Austin, Texas, United States
Drug Development, Inc.
Houston, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Countries
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References
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McElroy SL, Hudson JI, Mitchell JE, Wilfley D, Ferreira-Cornwell MC, Gao J, Wang J, Whitaker T, Jonas J, Gasior M. Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry. 2015 Mar;72(3):235-46. doi: 10.1001/jamapsychiatry.2014.2162.
Other Identifiers
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SPD489-208
Identifier Type: -
Identifier Source: org_study_id
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