Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
319 participants
INTERVENTIONAL
2015-10-31
2016-10-31
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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Dasotraline
Dasotraline 4, 6, 8 mg
Dasotraline
Dasotraline 4, 6, 8mg flexibly dosed once daily
Placebo
Placebo Comparator
Placebo
Placebo once daily
Interventions
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Dasotraline
Dasotraline 4, 6, 8mg flexibly dosed once daily
Placebo
Placebo once daily
Eligibility Criteria
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Inclusion Criteria
* Subject meets the following DSM 5 criteria for a diagnosis of BED. An episode of binge eating is characterized by both:
* Eating an amount of food larger than what most people would eat, in a discrete period of time (eg, 2 hours)
* Sense of lack of control over eating episode
* Binge-eating episodes are associated with ≥ 3 of the following:
* Eating much more rapidly than normal
* Eating until uncomfortably full
* Eating large amounts when not feeling hungry
* Eating alone because of embarrassment
* Feeling disgusted with oneself, guilty afterward
* Binge-eating episodes are also associated with marked distress regarding the episode and not associated with recurrent use of compensatory behavior (eg, bulimia nervosa).
* Diagnosis is confirmed based on the eating-disorders module of the SCID, clinician review of subject diaries, and the EDE Q.
* Subject has a BED diagnosis including at least 2 binge eating days a week for at least 6 months prior to screening.
* Subject's BED is of at least moderate severity.
* Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for any illicit drug.
* Female subject must have a negative serum pregnancy test at screening; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
* Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
* Subject must be able to comply with study drug administration and adhere to protocol requirements.
Subject can read well enough to understand the informed consent form and other subject materials.
Exclusion Criteria
* Subject has a lifetime history or current symptoms of bulimia nervosa or anorexia nervosa.
* Subject has started psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) within 3 months prior to screening. Note: Subjects receiving stable ongoing psychotherapy for longer than 3 months are permitted to enroll.
* Subject is participating in a formal weight loss program (eg, Weight Watchers®) within 3 months prior to screening.
* Subject has used a psychostimulant or mood stabilizer within the 3 months prior to screening.
* Subject has used any medications for the treatment of binge eating, other eating disorders, obesity, or weight gain or any other medication that could result in weight gain or weight loss including over-the-counter and herbal products within the 3 months prior to screening.
* Subject has a lifetime history of psychotic disorder, bipolar disorder, hypomania, dementia, or ADHD as defined by the DSM 5 criteria.
* Subject has a history of moderate to severe depression based on investigator's judgment within the 6 months prior to screening or is currently taking or has taken any medication for depression during the 3 months prior to screening.
* Subject has a history of substance use disorder including alcohol use disorder (excluding nicotine and caffeine) within the 12 months prior to screening, as defined by the DSM 5 criteria.
* Subject has MADRS score ≥ 18 at screening and Baseline visit.
* Subject is considered a suicide risk or has any previous history of suicide attempt.
* Subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C SSRS assessment at screening (in the past month). Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
* Subject has type I diabetes mellitus or insulin-dependent diabetes mellitus.
* Subject with type II diabetes mellitus has hemoglobin A1c ≥ 6.5% at screening, or has initiated treatment with or changed the dose of a glucose-lowering agent within 3 months prior to screening.
* Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, documented heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
* Subject has initiated treatment with or changed the dose of a lipid-lowering medication within the 3 months prior to screening.
* Subject has a history of moderate or severe hypertension that in the investigator's opinion has not been medically stable or has required a change in dosage and/or medication during the 3 months prior to screening.
* Subject has a history of epilepsy, seizures (except childhood febrile seizures), unexplained syncope or other unexplained blackouts (except single incident), or head trauma with loss of consciousness lasting more than 5 minutes, or a history of clinically significant repeated head-traumas without loss of consciousness.
* Subject is female and pregnant or nursing.
* Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
* Subject has a history of positive test for Hepatitis B surface antigen or Hepatitis C antibody with liver function test results at screening above the upper limit of normal (ULN) for the reference laboratory.
* Subject without a history of positive test for Hepatitis B surface antigen or Hepatitis C antibody has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value ≥ 2 times the ULN at screening.
* Subject has a blood urea nitrogen (BUN) value ≥ 1.5 times the ULN for the reference range, fasting blood glucose ≥ 126 mg/dL (7.0 mmol/L), or hemoglobin A1c ≥ 6.5% at screening.
* Subject is known to have tested positive for human immunodeficiency virus (HIV).
* Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the investigator considers to be inappropriate to allow participation in the study.
* The subject's screening ECG shows a corrected QT interval using Fridericia's formula (QTcF) of ≥ 450 msec for male subjects or ≥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.
* Subject has any life-time history of abuse or diversion of stimulants.
* Subject has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study drug formulation.
* Subject has enrolled in any Phase 2 or 3 trial of psychostimulants including lisdexamfetamine dimesylate (Vyvanse®) for binge-eating disorder.
* Subject is currently participating or has participated in any clinical trial within the last 90 days or has participated in more than 2 clinical trials within the past year. This includes studies using marketed compounds or devices.
* Subject has previously been enrolled in a clinical trial of dasotraline (SEP 225289).
* Subject is an investigational site staff member or the relative of an investigational site staff member.
18 Years
55 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dasotraline Medical Director, MD
Role: STUDY_DIRECTOR
Sunovioin
Locations
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Southern California Research
Beverly Hills, California, United States
Southwestern Research, Inc.
Beverly Hills, California, United States
Pharmacology Research Institute
Encino, California, United States
Collaborative NeuroScience Network Inc.
Garden Grove, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
PCSD- Feighner Research
San Diego, California, United States
Research Across America
Santa Ana, California, United States
Lytle and Weiss, PLLC
Denver, Colorado, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Institute of Advanced Medical Research
Alpharetta, Georgia, United States
Neurotrials Research, INC.
Atlanta, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Goldpoint Clinical Research, Inc.
Indianapolis, Indiana, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, United States
McLean Hospital
Belmont, Massachusetts, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Princeton Medical Institute, LCC
Princeton, New Jersey, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Radiant Research, Inc.
Akron, Ohio, United States
Patient Priority Clinical Sites
Cincinnati, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Lindner Center Of Hope
Mason, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
Oregon Center for Clinical Investigatons, INC.
Portland, Oregon, United States
Oregon Center for Clinical Investigatons, INC.
Salem, Oregon, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, United States
Radiant Research, Inc.
Anderson, South Carolina, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Furturesearch Trials of Dallas
Dallas, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Psychiatric Medical Associates
Plano, Texas, United States
Radiant Research, Inc.
Murray, Utah, United States
Advanced Research Institute
Ogden, Utah, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
NeuroScience, Inc.
Herndon, Virginia, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Countries
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References
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McElroy SL, Hudson JI, Grilo CM, Guerdjikova AI, Deng L, Koblan KS, Goldman R, Navia B, Hopkins S, Loebel A. Efficacy and Safety of Dasotraline in Adults With Binge-Eating Disorder: A Randomized, Placebo-Controlled, Flexible-Dose Clinical Trial. J Clin Psychiatry. 2020 Sep 8;81(5):19m13068. doi: 10.4088/JCP.19m13068.
Other Identifiers
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SEP360-221
Identifier Type: -
Identifier Source: org_study_id