A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Binge-Eating Disorder

In brief

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).

Key facts

Study ID

NCT05113953

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

147

Starts

2021-12-22

Expected to finish

2022-08-19

Last updated by the study team

2025-09-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 2 binge eating days per week for 6 months prior to screening.
• 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.

You may not qualify if…

• 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.

Where it is running

• NoesisPharma, LLC — Phoenix, Arizona, United States
• Southern California Research LLC — Beverly Hills, California, United States
• Pharmacology Research Institute - San Fernando Valley — Encino, California, United States
• Collaborative Neuroscience Research, LLC — Garden Grove, California, United States
• Pacific Clinical Research Management Group LLC — Upland, California, United States
• Mountain View Clinical Research, LLC — Denver, Colorado, United States
• Clinical Neuroscience Solutions - Jacksonville — Jacksonville, Florida, United States
• Miami Dade Medical Research Institute — Miami, Florida, United States
• iResearch Atlanta — Decatur, Georgia, United States
• Psych Atlanta, PC — Marietta, Georgia, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Collective Medical Research — Prairie Village, Kansas, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• St. Charles Psychiatric Associates & Midwest Research Group — Weldon Spring, Missouri, United States
• ActivMed Practices and Research - Portsmouth — Portsmouth, New Hampshire, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• Princeton Medical Institute — Princeton, New Jersey, United States
• Manhattan Behavioral Medicine — New York, New York, United States
• Medical Research Network, LLC — New York, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Craig and Frances Linder Center of Hope — Mason, Ohio, United States
• Clinical Neuroscience Solutions, Inc. — Memphis, Tennessee, United States
• Psychiatry + Psychotherapy Partners Austin — Austin, Texas, United States
• FutureSearch Trials - Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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