Dasotraline Binge Eating Disorder Study
A 12-week, Randomized, Double-blind, Parallel-group, Placebo Controlled, Flexibly Dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Severe Binge Eating Disorder
1 other identifier
interventional
319
1 country
43
Brief Summary
Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with moderate to severe Binge Eating Disorder (BED)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2015
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedSeptember 28, 2017
September 1, 2017
1 year
September 29, 2015
September 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in number of binge days (defined as days during which at least 1 binge episode occurs) per week to Week 12
12 Weeks
Secondary Outcomes (21)
Change from baseline in number of binge episodes per week to Weeks 1, 2, 3, 4, 6, 8, 10, and 12
12 Weeks
Percent of subjects with a 4-week cessation from binge eating (defined as a 100% reduction for at least 28 consecutive days in the number of binge eating episodes prior to the EOT visit)
4 weeks
Change from baseline in Clinical Global Impression-Severity (CGI S) score at Weeks 2, 4, 6, 8, 10, and 12
12 Weeks
Change from baseline in Eating Disorder Examination Questionnaire Brief Version (EDE Q7) global score and 3 subscale scores (dietary restraint, shape/weight overvaluation, and body dissatisfaction) at Weeks 4, 8, and 12
12 Weeks
Change from baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y BOCS BE) total score and subscale scores (obsessions and compulsions) at Weeks 2, 4, 6, 8, 10, and 12
12 Weeks
- +16 more secondary outcomes
Study Arms (2)
Dasotraline
EXPERIMENTALDasotraline 4, 6, 8 mg
Placebo
PLACEBO COMPARATORPlacebo Comparator
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subject between 18 and 55 years of age, inclusive, at time of informed consent.
- 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.
- +4 more criteria
You may not qualify if:
- Subject has body weight index (BMI) of 18 kg/m2or less or greater than 45 kg/m2.
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Southern California Research
Beverly Hills, California, 90210, United States
Southwestern Research, Inc.
Beverly Hills, California, 90210, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Collaborative NeuroScience Network Inc.
Garden Grove, California, 92845, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
PCSD- Feighner Research
San Diego, California, 92108, United States
Research Across America
Santa Ana, California, 92705, United States
Lytle and Weiss, PLLC
Denver, Colorado, 80209, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Institute of Advanced Medical Research
Alpharetta, Georgia, 30005, United States
Neurotrials Research, INC.
Atlanta, Georgia, 30342, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Goldpoint Clinical Research, Inc.
Indianapolis, Indiana, 46260, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226, United States
McLean Hospital
Belmont, Massachusetts, 02478, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304, United States
Princeton Medical Institute, LCC
Princeton, New Jersey, 08540, United States
Bioscience Research, LLC
Mount Kisco, New York, 10549, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Radiant Research, Inc.
Akron, Ohio, 44311, United States
Patient Priority Clinical Sites
Cincinnati, Ohio, 45215, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Lindner Center Of Hope
Mason, Ohio, 45040, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Sunstone Medical Research, LLC
Medford, Oregon, 97504, United States
Oregon Center for Clinical Investigatons, INC.
Portland, Oregon, 97214, United States
Oregon Center for Clinical Investigatons, INC.
Salem, Oregon, 97301, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18104, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
Radiant Research, Inc.
Greer, South Carolina, 29650, United States
Furturesearch Trials of Dallas
Dallas, Texas, 75231, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Psychiatric Medical Associates
Plano, Texas, 75093, United States
Radiant Research, Inc.
Murray, Utah, 84123, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Neuropsychiatric Associates
Woodstock, Vermont, 05091, United States
NeuroScience, Inc.
Herndon, Virginia, 20170, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 32926604DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dasotraline Medical Director, MD
Sunovioin
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
September 30, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
September 28, 2017
Record last verified: 2017-09