SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Binge Eating Disorder

In brief

The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary

Key facts

Study ID

NCT01718509

Run by

Shire

People needed

390

Starts

2012-11-26

Expected to finish

2013-09-20

Last updated by the study team

2021-07-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:
• Subject is between 18-55 years of age.
• Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
• Subject has a BED diagnosis.
• Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
• 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.

You may not qualify if…

• Subjects are excluded from the study if any of the following exclusion criteria are met:
• Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
• Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED.
• Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
• Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
• Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
• 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.
• Subject has a history of moderate or severe hypertension.
• Subject is female and pregnant or nursing.
• Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Where it is running

• 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

Full record on ClinicalTrials.gov

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