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

Last updated: August 19, 2025
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Completed

Phase

2

Condition

Binge Eating Disorder

Bulimia

Treatment

Placebo

Centanafadine

Clinical Study ID

NCT05113953
405-201-00056
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants 18 to 65 years of age (inclusive) at the time of informedconsent.

  • A primary diagnosis of BED, or is diagnosed at screening, according to Diagnosticand Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria andconfirmed 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 toscreening.

  • A rating of 4 or higher on the Clinical Global Impression - Severity (CGI-S) atscreening and baseline.

  • Body mass index (BMI) of 18 to 45 kg/m^2, inclusive.

Exclusion

Exclusion Criteria:

  • Lifetime history of bulimia nervosa or anorexia nervosa.

  • Participation in a formal weight loss program within 3 months of screening orplanning to start a weight loss program during the trial.

  • History of bariatric surgery.

  • Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 18.

Study Design

Total Participants: 147
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 22, 2021
Estimated Completion Date:
August 19, 2022

Connect with a study center

  • NoesisPharma, LLC

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • NoesisPharma, LLC

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Site Not Available

  • Southern California Research LLC

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Pharmacology Research Institute - San Fernando Valley

    Encino, California 91316
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Garden Grove, California 92845
    United States

    Site Not Available

  • Pacific Clinical Research Management Group LLC

    Upland, California 91786
    United States

    Site Not Available

  • Southern California Research LLC

    Beverly Hills 5328041, California 5332921 90210
    United States

    Site Not Available

  • Pharmacology Research Institute - San Fernando Valley

    Encino 5346649, California 5332921 91316
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Garden Grove 5351515, California 5332921 92845
    United States

    Site Not Available

  • Pacific Clinical Research Management Group LLC

    Upland 5404915, California 5332921 91786
    United States

    Site Not Available

  • Mountain View Clinical Research, LLC

    Denver, Colorado 80209
    United States

    Site Not Available

  • Mountain View Clinical Research, LLC

    Denver 5419384, Colorado 5417618 80209
    United States

    Site Not Available

  • Clinical Neuroscience Solutions - Jacksonville

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Miami Dade Medical Research Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • Clinical Neuroscience Solutions - Jacksonville

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Miami Dade Medical Research Institute

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Psych Atlanta, PC

    Marietta, Georgia 30060
    United States

    Site Not Available

  • iResearch Atlanta

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Psych Atlanta, PC

    Marietta 4207783, Georgia 4197000 30060
    United States

    Site Not Available

  • Psychiatric Associates

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Collective Medical Research

    Prairie Village, Kansas 66208
    United States

    Site Not Available

  • Psychiatric Associates

    Overland Park 4276873, Kansas 4273857 66211
    United States

    Site Not Available

  • Collective Medical Research

    Prairie Village 4277718, Kansas 4273857 66208
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston 4930956, Massachusetts 6254926 02131
    United States

    Site Not Available

  • St. Charles Psychiatric Associates & Midwest Research Group

    Weldon Spring, Missouri 63304
    United States

    Site Not Available

  • St. Charles Psychiatric Associates & Midwest Research Group

    Weldon Spring 4413926, Missouri 4398678 63304
    United States

    Site Not Available

  • ActivMed Practices and Research - Portsmouth

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • ActivMed Practices and Research - Portsmouth

    Portsmouth 5091383, New Hampshire 5090174 03801
    United States

    Site Not Available

  • Center for Emotional Fitness

    Cherry Hill, New Jersey 08002
    United States

    Site Not Available

  • Princeton Medical Institute

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Center for Emotional Fitness

    Cherry Hill 4501198, New Jersey 5101760 08002
    United States

    Site Not Available

  • Princeton Medical Institute

    Princeton 5102922, New Jersey 5101760 08540
    United States

    Site Not Available

  • Manhattan Behavioral Medicine

    New York, New York 10036
    United States

    Site Not Available

  • Medical Research Network, LLC

    New York, New York 10128
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10312
    United States

    Site Not Available

  • Manhattan Behavioral Medicine

    New York 5128581, New York 5128638 10036
    United States

    Site Not Available

  • Medical Research Network, LLC

    New York 5128581, New York 5128638 10128
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island 5139568, New York 5128638 10312
    United States

    Site Not Available

  • Midwest Clinical Research Center

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Craig and Frances Linder Center of Hope

    Mason, Ohio 45040
    United States

    Site Not Available

  • Midwest Clinical Research Center

    Dayton 4509884, Ohio 5165418 45417
    United States

    Site Not Available

  • Craig and Frances Linder Center of Hope

    Mason 4517698, Ohio 5165418 45040
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Site Not Available

  • Psychiatry + Psychotherapy Partners Austin

    Austin, Texas 78737
    United States

    Site Not Available

  • FutureSearch Trials - Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Psychiatry + Psychotherapy Partners Austin

    Austin 4671654, Texas 4736286 78737
    United States

    Site Not Available

  • FutureSearch Trials - Dallas

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

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