SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
NCT ID: NCT01718509
Last Updated: 2021-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2012-11-26
2013-09-20
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
DOUBLE
Study Groups
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SPD489 (Lisdexamfetamine dimesylate)
SPD489 (Lisdexamfetamine dimesylate)
50 or 70 mg administered orally, once-daily for up to 12 weeks
Placebo
Placebo
Administered once-daily, orally, for up to 12 weeks
Interventions
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SPD489 (Lisdexamfetamine dimesylate)
50 or 70 mg administered orally, once-daily for up to 12 weeks
Placebo
Administered once-daily, orally, for up to 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
3. Subject has a BED diagnosis.
4. Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
5. Female subjects must have a negative serum B-HCG pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements.
Exclusion Criteria
2. Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED.
3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
5. Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
6. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
7. Subject has a history of moderate or severe hypertension.
8. Subject is female and pregnant or nursing.
9. Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
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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Radiant Research, Inc.
Tucson, Arizona, United States
Southern California Research, LLC
Beverly Hills, California, United States
Scripps Clinical Research Services
La Jolla, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Excel Research, Inc.
Oceanside, California, United States
PCSD - Feighner Research
San Diego, California, United States
Radiant Research, Inc.
Denver, Colorado, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
American Medical Research
Oak Brook, Illinois, United States
Deaconess Clinic Gateway Health Center
Newburgh, Indiana, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States
Potomac Grove Clinical Research Center
Gaithersburg, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Activmed Practices and Research
Haverhill, Massachusetts, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
UMN Medical School, Dept of Psychiatry
Minneapolis, Minnesota, United States
Scientella, LLA
St Louis, Missouri, United States
Robert Lynn Horne, MD, LTD
Las Vegas, Nevada, United States
Global Medical Inst LLC; Princeton Medical Institute
Princeton, New Jersey, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
CNS Clinica at the Brain Resource Center
New York, New York, United States
Radiant Research, Inc.
Akron, Ohio, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, United States
The Craig and Frances Lindner Center of Hope
Mason, Ohio, United States
Clinical Trials of America, Inc.
Eugene, Oregon, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
Oregon Center for Clinical Investigators (OCCI, Inc)
Portland, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
CRI Lifetree
Philadelphia, Pennsylvania, United States
Omega Medical Reserach
Warwick, Rhode Island, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Psychiatric Medical Associates
Plano, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
NeuroScience, Inc.
Herndon, Virginia, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, United States
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
Klinische Forschung Berlin Buch GmbH
Berlin, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Countries
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References
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McElroy SL, Hudson J, Ferreira-Cornwell MC, Radewonuk J, Whitaker T, Gasior M. Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials. Neuropsychopharmacology. 2016 Apr;41(5):1251-60. doi: 10.1038/npp.2015.275. Epub 2015 Sep 9.
Robertson B, Wu J, Fant RV, Schnoll SH, McElroy SL. Assessment of Amphetamine Withdrawal Symptoms of Lisdexamfetamine Dimesylate Treatment for Adults With Binge-Eating Disorder. Prim Care Companion CNS Disord. 2020 Mar 26;22(2):19m02540. doi: 10.4088/PCC.19m02540.
Kornstein SG, Bliss C, Kando J, Madhoo M. Clinical Characteristics and Treatment Response to Lisdexamfetamine Dimesylate Versus Placebo in Adults With Binge Eating Disorder: Analysis by Gender and Age. J Clin Psychiatry. 2019 Feb 26;80(2):18m12378. doi: 10.4088/JCP.18m12378.
Sheehan DV, Gasior M, McElroy SL, Radewonuk J, Herman BK, Hudson J. Effects of Lisdexamfetamine Dimesylate on Functional Impairment Measured on the Sheehan Disability Scale in Adults With Moderate-to-severe Binge Eating Disorder: Results from Two Randomized, Placebo-controlled Trials. Innov Clin Neurosci. 2018 Jun 1;15(5-6):22-29.
Citrome L, Kando JC, Bliss C. Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies. Neuropsychiatr Dis Treat. 2018 Feb 15;14:537-546. doi: 10.2147/NDT.S158395. eCollection 2018.
Other Identifiers
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2012-003310-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD489-344
Identifier Type: -
Identifier Source: org_study_id
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