A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
- Registration Number
- NCT05113953
- Brief Summary
The primary objective of this study is to assess the efficacy of 2 doses of centanafadine sustained-release (SR) (200 milligrams \[mg\] and 400 mg total daily dose \[TDD\]) compared with placebo in adults with moderate to severe binge eating disorder (BED).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
- Adult participants 18 to 65 years of age (inclusive) at the time of informed consent.
- A primary diagnosis of BED, or is diagnosed at screening, according to Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Structured Clinical Interview for DSM-5 (SCID).
- BED with a history of at least moderate severity.
- A rating of 4 or higher on the Clinical Global Impression - Severity (CGI-S) at screening and baseline.
- Body mass index (BMI) of 18 to 45 kg/m^2, inclusive.
- Lifetime history of bulimia nervosa or anorexia nervosa.
- Participation in a formal weight loss program within 3 months of screening or planning to start a weight loss program during the trial.
- History of bariatric surgery.
- Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 18.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received centanafadine matching placebo tablets, orally, BID for 8 weeks. Centanafadine 200 mg Placebo Participants received centanafadine 100 mg SR tablets, orally, BID at a TDD of 200 mg along with centanafadine matching placebo tablets, orally, BID for 8 weeks. Centanafadine 400 mg Centanafadine Participants received centanafadine 200 mg SR tablets, orally, twice daily (BID) at a TDD of 400 mg for 8 weeks. Centanafadine 200 mg Centanafadine Participants received centanafadine 100 mg SR tablets, orally, BID at a TDD of 200 mg along with centanafadine matching placebo tablets, orally, BID for 8 weeks.
- Primary Outcome Measures
Name Time Method Change from Baseline in Number of Binge Eating Days per Week Baseline up to Week 8 Having a binge eating day is defined as a day with at least one binge eating episode.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score Up to Week 8 Y-BOCS-BE will be measured on a 10-item scale with each item rated from 0-4 where a higher score indicates more extreme symptoms.
Change from Baseline in Number of Binge Episodes per Week Up to Week 8 Clinical Global Impression - Change (CGI-C) Score Up to Week 8 CGI-C will be measured on a scale from 1-7 where a higher score indicates worse disease progression.
Number of Participants with Four-Week Cessation from Binging Up to Week 8 Change from Baseline in Patient Global Impression - Severity (PGI-S) Score Up to Week 8 PGI-S will be measured on a scale from 1-7 where a higher score indicates more severe symptoms.
Patient Global Impression - Change (PGI-C) Score Up to Week 8 PGI-C will be measured on a scale from 1-7 where a higher score indicates a more severe disease progression.
Change from Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Score Up to Week 8 SF-36v2 will be measured on a scale from 1-100 where a lower total score (created by combining PCS and MCS scores) indicates a lower health-related quality of life.
Change from Baseline in Eating Disorder Examination Questionnaire - 7-Item Version (EDE-Q7) Total Score Up to Week 8 EDE-Q7 will be measured on a 7 item scale from 0-6 where a higher score indicates a more severe outcome.
Number of Participants with Adverse Events (AEs) Day 1 up to 7 days after last dose of study treatment (up to approximately 9 weeks) Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score Weeks 1, 2, 3, 4, 6, 8 CGI-S will be measured on a scale from 1-7 where a higher score indicates a more severe outcome.
Trial Locations
- Locations (25)
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Psych Atlanta, PC
🇺🇸Marietta, Georgia, United States
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Craig and Frances Linder Center of Hope
🇺🇸Mason, Ohio, United States
Pharmacology Research Institute - San Fernando Valley
🇺🇸Encino, California, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
FutureSearch Trials - Dallas
🇺🇸Dallas, Texas, United States
Collective Medical Research
🇺🇸Prairie Village, Kansas, United States
Medical Research Network, LLC
🇺🇸New York, New York, United States
Psychiatry + Psychotherapy Partners Austin
🇺🇸Austin, Texas, United States
Manhattan Behavioral Medicine
🇺🇸New York, New York, United States
Southern California Research LLC
🇺🇸Beverly Hills, California, United States
Clinical Neuroscience Solutions - Jacksonville
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Collaborative Neuroscience Research, LLC
🇺🇸Garden Grove, California, United States
Pacific Clinical Research Management Group LLC
🇺🇸Upland, California, United States
ActivMed Practices and Research - Portsmouth
🇺🇸Portsmouth, New Hampshire, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
NoesisPharma, LLC
🇺🇸Phoenix, Arizona, United States
Mountain View Clinical Research, LLC
🇺🇸Denver, Colorado, United States
Miami Dade Medical Research Institute
🇺🇸Miami, Florida, United States
St. Charles Psychiatric Associates & Midwest Research Group
🇺🇸Weldon Spring, Missouri, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States