Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
Condition: Attention Deficit Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate Hydrochloride Extended Release Capsule; Placebo
Intervention description: An optimized dose of Methylphenidate Hydrochloride Extended Release Capsules 15, 20, 30 or 40 mg to be dosed once daily; Capsule without active drug
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All subjects entered the Open-Label Dose optimization phase and were titrated until an optimized dose of Methylphenidate hydrochloride Extended Release capsule was achieved. Completing subjects then entered the randomized Double-blind Phase (crossover).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Attention deficit; Hyperactivity; Impulsivity; Inattention

Summary:

      The time course of response following one dose of a new methylphenidate hydrochloride
      extended release capsule is studied in children 6-12 years in a simulated laboratory
      classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been
      formulated for daily dosing to provide treatment of a child with Attention deficit
      hyperactivity disorder (ADHD) for the substantial day.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females ages 6 to 12.

          2. ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile.

          3. In need of treatment for ADHD and able to have 2-day washout from previous medication.

          4. Females of child-bearing potential not pregnant and practice birth control.

          5. Subject and parent/guardian willing to comply with protocol.

          6. Signed consent and assent.

        Exclusion Criteria:

          1. Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of
             Intelligence.

          2. Current primary psychiatric diagnosis of: severe anxiety disorder, conduct disorder,
             psychotic disorders, pervasive developmental disorder, eating disorder,
             obsessive-compulsive disorder, major depressive disorder, bipolar disorder, substance
             use disorder, chronic tic disorder, personal or family history of Tourette's Syndrome.

          3. Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family
             history of sudden death, glaucoma.

          4. Use of psychotropic CNS meds having effect exceeding 14 days from screening.

          5. Planned use of prohibited drugs.

          6. Is pregnant or breast-feeding.

          7. Significant ECG or laboratory abnormalities.

          8. Experimental drug or medical device within 30 days prior to screening.

          9. Hypersensitivity to methylphenidate.

         10. Inability or unwillingness to comply with protocol.

         11. Well controlled on current ADHD treatment.

         12. Inability to take oral capsules.