The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
Condition: Adult Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: OPC-64005; Atomoxetine; Placebo
Intervention description: OPC-64005 film coated tablets; Atomoxetine gelatin capsules; OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: ADHD; ADD

Summary:

      A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult
      attention-deficit/hyperactivity disorder.
    

Eligibility criteria:

        Inclusion Criteria (Screening):

          -  Male and female participants 18 to 55 years of age, inclusive, at the time of informed
             consent.

          -  Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th
             edition (DSM-5) diagnosis of ADHD (including predominantly inattentive presentation,
             hyperactive presentation, and combined presentations) as confirmed by the Adult ADHD
             Clinical Diagnostic Scale (ACDS) v 1.2.

          -  Participants willing to discontinue all prohibited psychotropic medication starting
             from the time of signing the informed consent and up to the 30 (+ 2)-day follow-up
             period.

        Exclusion Criteria:

          -  Participants with a history of inadequate response or suboptimal tolerability to
             atomoxetine.

          -  Participants who report allergies (lifetime treatment history) to stimulant or
             nonstimulant ADHD medications.

          -  Participants with other DSM-5 disorders including psychosis (current or lifetime),
             bipolar disorder (current or lifetime), current major depressive disorder, or current
             panic disorder; or another psychiatric diagnosis that the investigator believes is
             primary or that will confound efficacy or safety assessments of the trail or interfere
             with participation in the trial otherwise.

          -  Participants with a clinically significant current DSM-5 diagnosis of borderline,
             antisocial, paranoid, schizoid, schizotypal, histrionic, narcissistic, avoidant,
             obsessive compulsive, or dependent personality disorders.

          -  Participants who currently have clinically significant dermatological, neurological,
             hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or
             gastrointestinal disorders such as any history of myocardial infarction, congestive
             heart failure, HIV (human immunodeficiency virus) seropositive status/acquired
             immunodeficiency syndrome, or active or chronic hepatitis B or C.

          -  Participants with a history of obstructive sleep apnea.