A Study to Test the Effects of Centanafadine in Adults With Attention‑deficit/Hyperactivity Disorder and Emotional Dysregulation

Sponsor ID
405-201-00231
Clinicaltrials.gov ID
NCT07759154
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Recruiting
Sponsor ID
405-201-00231
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • ADHD
  • Emotional Dysregulation
    • Sex
    Female & Male
    Trial Dates
    Sep 2026 - May 2027
    Healthy Volunteers
    No
    • Inclusion Criteria
    • Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).
    • Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.
    • Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.
    • CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.
    • Exclusion Criteria
    • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a lifetime diagnosis of bipolar and related disorders, schizophrenia spectrum and other psychotic disorders, borderline and antisocial personality disorders, neurocognitive disorders, autism spectrum disorder, or intellectual disability.
    • DSM-5 criteria for a current diagnosis of major depressive disorder, post-traumatic stress disorder, any substance use disorder, untreated/unstable obstructive sleep apnea, eating disorders, or obsessive compulsive disorder.
    • Any other current DSM-5 comorbid psychiatric disorder identified by the Mini International Neuropsychiatric Interview (MINI) or any medical condition that, in the judgment of the investigator, could be expected to require treatment with medications prohibited in this trial that cannot be safely discontinued with completion of an appropriate washout, could confound efficacy or safety assessments, or be the primary driver of ED.
    • Presence of an unstable or uncontrolled medical condition that, in the opinion of the investigator, could pose a safety risk to the participant or could manifest with psychiatric symptoms (eg, thyroid disease).
    • In the clinical opinion of the investigator, the participant has not derived significant therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate, or amphetamine and atomoxetine) given with an acceptable dose and duration during adulthood (aged 18 years or older).
    • Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment.
    • Any disorder that is the primary focus of treatment other than ADHD.
    • Evidence of current substance use disorder or history in the past 12 months.
    • History of any prior exposure to centanafadine.
    • Participated in other clinical trials involving investigational drugs within 180 days prior to screening or participated in more than 2 interventional clinical trials involving investigational drugs within the past year.
    • Have an allergy to the IMP or any component of the IMP.
    • Note: Other protocol-specified inclusion/exclusion criteria may apply.

    Study Summary

    The primary purpose of this study is to evaluate the efficacy of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Centanafadine XR
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    80
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Inclusion Criteria
    • 1. Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • Inclusion Criteria
    • Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).
    • Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.
    • Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.
    • CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.
    • Exclusion Criteria
    • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a lifetime diagnosis of bipolar and related disorders, schizophrenia spectrum and other psychotic disorders, borderline and antisocial personality disorders, neurocognitive disorders, autism spectrum disorder, or intellectual disability.
    • DSM-5 criteria for a current diagnosis of major depressive disorder, post-traumatic stress disorder, any substance use disorder, untreated/unstable obstructive sleep apnea, eating disorders, or obsessive compulsive disorder.
    • Any other current DSM-5 comorbid psychiatric disorder identified by the Mini International Neuropsychiatric Interview (MINI) or any medical condition that, in the judgment of the investigator, could be expected to require treatment with medications prohibited in this trial that cannot be safely discontinued with completion of an appropriate washout, could confound efficacy or safety assessments, or be the primary driver of ED.
    • Presence of an unstable or uncontrolled medical condition that, in the opinion of the investigator, could pose a safety risk to the participant or could manifest with psychiatric symptoms (eg, thyroid disease).
    • In the clinical opinion of the investigator, the participant has not derived significant therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate, or amphetamine and atomoxetine) given with an acceptable dose and duration during adulthood (aged 18 years or older).
    • Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment.
    • Any disorder that is the primary focus of treatment other than ADHD.
    • Evidence of current substance use disorder or history in the past 12 months.
    • History of any prior exposure to centanafadine.
    • Participated in other clinical trials involving investigational drugs within 180 days prior to screening or participated in more than 2 interventional clinical trials involving investigational drugs within the past year.
    • Have an allergy to the IMP or any component of the IMP.
    • Note: Other protocol-specified inclusion/exclusion criteria may apply.

    Locations

    Location
    Status
    Location
    Sarkis Clinical Trials - Gainesville
    Gainesville, Florida, United States, 32607
    Status
    Not yet recruiting
    Location
    CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville)
    Jacksonville, Florida, United States, 32256
    Status
    Not yet recruiting
    Location
    Accel Research Sites-Maitland
    Maitland, Florida, United States, 32751
    Status
    Not yet recruiting
    Location
    Nola Research Works
    New Orleans, Louisiana, United States, 70125
    Status
    Recruiting
    Location
    Boston Clinical Trials
    Boston, Massachusetts, United States, 02132
    Status
    Not yet recruiting
    Location
    Adams Clinical - Watertown
    Watertown, Massachusetts, United States, 02472
    Status
    Not yet recruiting
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