Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Adhansia XR; Concerta
Intervention description: Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg); An osmotic-controlled oral release delivery system (OROS) of methylphenidate HCl (MPH) extended-release tablets taken once daily (18 mg, 27 mg, 36 mg, and 54 mg)
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 267.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; Methylphenidate; Adhansia XR; MPH; OROS; Phase IV

Summary:

      The purpose of this study is to investigate the treatment effectiveness of Adhansia XR at
      month-2 after initiation, and the effectiveness of Adhansia XR overall and when compared with
      the active comparator group (Concerta) over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a physician-confirmed diagnosis of ADHD per Diagnostic and Statistical
             Manual of Mental Disorders (DSM-5) criteria and the health care practitioner (HCP) has
             made the decision to prescribe an extended-release methylphenidate (ER MPH) product to
             the patient for potential improvement of symptoms throughout and later in the day,
             independent of this study.

          -  Patient must be 12 years of age or older.

          -  Patient must be eligible to receive Adhansia XR or osmotic- release oral delivery
             system methylphenidate ([OROS MPH] or Concerta) according to the US product labels; a
             patient must be eligible and willing to receive either drug, as randomization will
             assign them to a specific treatment group. Patient may be treatment-experienced or
             naïve to pharmacological therapy for ADHD, so long as all inclusion and no exclusion
             criteria are met.

          -  Patient must be willing to take only the assigned study medication per HCP
             instructions based on FDA label guidance for treatment of their ADHD for the first 2
             months of the study (i.e. full titration period). Patients should not be on any other
             medication, or starting any new non-medication treatment, proven to have effect on
             ADHD in the first two months of the study.

        Exclusion Criteria:

          -  Concurrent participation in an investigational study in which patient assessment
             and/or treatment may be dictated by a protocol.

          -  Patients with a true allergy to methylphenidate (MPH), amphetamine (AMP), or
             sympathomimetic amines, history of serious adverse reactions to MPH or AMP or be known
             to be non-responsive to MPH or AMP treatment.

          -  Patient is currently stable on their ADHD treatment regimen.

          -  Female patients of child bearing potential who are pregnant, planning on becoming
             pregnant or breastfeeding.

          -  Patient with any known conditions that are contraindicated for either Adhansia XR or
             OROS MPH (or Concerta) use, as documented in the US Full Prescribing Information,
             including patients with any known serious structural cardiac abnormalities,
             cardiomyopathy, serious heart arrhythmias, or coronary artery disease.

          -  Patients with a known sensitivity to the food dye tartrazine (Federal Food, Drug, and
             Cosmetic Yellow No. 5).

          -  Suicidal Ideation

               -  The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered at
                  screening and at Month-2, Month-4, and Month-6, but also depends on the judgment
                  of the HCP.

          -  Inability or unwillingness of the patient (or parent/guardian if patient is a minor)
             to complete the study-required electronic questionnaires and provide required
             information through electronic means.