A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
Condition: Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Centanafadine SR; Placebo; Centanafadine SR
Intervention description: 100 mg, BID, oral tablets; BID, oral tablet.; 200 mg, BID, oral tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 604.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Centanafadine; ADHD; ADD

Summary:

      This study evaluates the efficacy, safety, and tolerability of centanafadine
      sustained-release tablets in adults with attention-deficit/hyperactivity disorder (ADHD).
      Participants will either receive a twice-daily dose of centanafadine sustained-release
      tablets, or twice-daily placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must meet the Diagnostic and Statistical Manual of Mental Disorders Fifth
             Edition (DSM-5) criteria for ADHD (including predominantly inattentive presentation,
             hyperactive presentation, or combined presentation) as confirmed by the Adult ADHD
             Clinical Diagnostic Scale (ACDS) Version 1.2. To confirm that ADHD is the primary
             diagnosis, the Mini International Neuropsychiatric Interview (MINI) will be used to
             identify and exclude other psychiatric conditions which would preclude enrollment.

          -  Participants who were not receiving any pharmacological treatment for ADHD must have
             an Adult ADHD Investigator Symptom Rating Scale (AISRS) score of ≥ 28 at screening and
             baseline. Participants who were receiving pharmacological treatment for ADHD at
             screening must have a minimum AISRS score of ≥ 22 at screening, and a score of ≥ 28 at
             baseline.

          -  All participants must be willing to discontinue all prohibited psychotropic
             medications starting from the time of signing the informed consent through the 7-day
             follow-up period. Participants that do not rollover into Trial 405-201-00015
             (NCT03605849) must be willing to discontinue all prohibited psychotropic medications
             starting from the time of signing the informed consent until after the follow-up
             telephone call 10 days after the last dose of investigational medicinal product (IMP).

          -  Participants must have a Clinical Global Impression-Severity of Illness Scale (CGI-S)
             score of ≥ 4 (≥ moderate impairment) at baseline.

        Exclusion Criteria:

          -  Participants with a DSM-5 diagnosis of Other Specified or Unspecified Attention
             Deficit/Hyperactivity Disorder.

          -  Participants has a current comorbid psychiatric disorder that either could be expected
             to require treatment with medications prohibited in this trial, or to confound
             efficacy or safety assessments. Examples include, but are not limited to, psychotic
             disorder, bipolar disorder, generalized anxiety disorder, obsessive-compulsive
             disorder, panic disorder, a current major depressive episode, or posttraumatic stress
             disorder, as established by the Mini International Neuropsychiatric Interview (MINI).

          -  In the opinion of the investigator, participants has not derived significant
             therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg,
             amphetamine and methylphenidate) given with an acceptable dose and duration during
             adulthood (aged 18 or older). NOTE: If participants has not derived significant
             therapeutic benefit due to an inability to tolerate side effects, eligibility can be
             discussed on case-by-case basis with the medical monitor.

          -  Participants who have a positive alcohol test (via breathalyzer or blood), a positive
             drug screen assessed prior to the baseline visit for cocaine, other illicit drugs
             (including marijuana), or prescription or over-the-counter (OTC) ADHD medications will
             be early terminated. This includes medications such as opioids or benzodiazepines
             taken without prescription.

          -  In the opinion of the investigator, the participants is unable to adhere to the
             treatment regimen or other requirements outlined in the protocol.