Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
NCT ID: NCT02009163
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
418 participants
INTERVENTIONAL
2014-01-27
2015-04-08
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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Lisdexamfetamine dimesylate
Administer one capsule (50 or 70 mg) orally daily at approximately 7:00 AM.
Lisdexamfetamine dimesylate
SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods)
Placebo
Administer one capsule orally daily at approximately 7:00 AM.
Placebo
Placebo capsule once per day (double-blind period)
Interventions
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Lisdexamfetamine dimesylate
SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods)
Placebo
Placebo capsule once per day (double-blind period)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject meets the following criteria for a diagnosis of BED:
* Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a 2-hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and a sense of lack of control over the eating (eg, a feeling that one cannot stop eating or control what or how much one is eating).
* The binge eating episodes are associated with at least 3 of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
* Marked distress regarding binge eating.
* The binge eating occurs, on average, at least 2 days a week for 6 months.
* The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
3. Subject is consistently able to swallow a capsule.
Exclusion Criteria
2. Subject is receiving psychotherapy or weight loss support within the past 3 months.
3. Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
4. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
5. Subject has abnormal thyroid function.
6. Subject initiated treatment with a lipid lowering medication within the past 3 months.
7. Subject has a history of moderate or severe hypertension.
8. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
9. Subject has glaucoma.
10. Subject is female and pregnant or nursing.
11. Subjects who have 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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Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Innovative Clinical Research, Inc
Lauderhill, Florida, United States
Compass Research LLC North Clinic
Leesburg, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Scientific Clinical Research, Inc
North Miami, 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
Goldpoint Clinical Research
Indianapolis, Indiana, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Louisiana Research Associates, Inc
New Orleans, Louisiana, United States
McLean Hospital
Belmont, Massachusetts, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
HBSA-Pacific Institute for Research & Evaluation
Albuquerque, New Mexico, United States
Brooklyn Medical Institute
Brooklyn, New York, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Linder Center of Hope
Mason, Ohio, United States
Oregon Center for Clinical Investigations, Inc (OCCI, Inc)
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc (OCCI, Inc)
Salem, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Radiant Research, Inc
Anderson, South Carolina, United States
Radiant Research, Inc
Greer, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Neuroscience Solution, Inc
Memphis, Tennessee, United States
FutureSearch Clinical Trials, LP
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Texas Center for Drug Development, Inc
Houston, Texas, United States
Research Across America
Plano, Texas, United States
Radiant Research, Inc
San Antonio, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Anxiety and Mood Disorder Center
Mississauga, Ontario, Canada
Manna Research
Pointe-Claire, Quebec, Canada
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
EMOVIS GmbH - Klinische Forschung
Berlin, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, , Germany
Forschung Schwerin GmbH, Friedrichstrasse 1
Schwerin, , Germany
Studienzentrum Nordwest
Westerstede, , Germany
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital del Henares
Madrid, , Spain
Lakarmottagningen Ekdahl & Kronberg
Malmo, , Sweden
Sofiahemmet
Stockholm, , Sweden
Stockholm Center for Eating Disorders
Stockholm, , Sweden
Countries
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References
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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.
Hudson JI, McElroy SL, Ferreira-Cornwell MC, Radewonuk J, Gasior M. Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):903-910. doi: 10.1001/jamapsychiatry.2017.1889.
Other Identifiers
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2012-004457-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD489-346
Identifier Type: -
Identifier Source: org_study_id
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