Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate HCl ER Capsules, 10 mg; Methylphenidate HCl ER Capsules, 15 mg; Methylphenidate HCl ER Capsules, 20 mg
Intervention description: Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg administered once daily in the morning; Methylphenidate Hydrochloride Extended-Release Capsules, 15 mg administered once daily in the morning; Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg administered once daily in the morning
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, single-dose
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 4 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: ADHD; Children; Pharmacokinetics

Summary:

      To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate
      hydrochloride extended-release) capsules under fed conditions in male or female children 4 to
      under 6 years of age with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is a male or female between the ages of 4 and under 6 years old.

          2. Patient has a history consistent with ADHD, meets the Diagnostic and Statistical
             Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD, inattentive,
             hyperactivity or combined.

          3. Patient must meet criteria for ADHD diagnosis on Kiddie Schedule for Affective
             Disorders and Schizophrenia for School-Age Children-Present and Lifetime (KSADS-PL)
             and clinical interview by experienced clinician; symptoms must have been present for
             at least 6 months.

          4. Subject has had prior behavioral treatment or subject's symptoms are severe enough to
             warrant treatment without prior behavioral treatment, and patient is on a stable dose
             of either immediate-release or extended-release methylphenidate.

          5. Subject must have age- and sex-adjusted ratings of ≥ 90th percentile Total Score on
             the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool
             Version, a Clinical Global Impressions -Severity Score of ≥4 and a Child Global
             Assessment Scale rating of <65 after methylphenidate washout and prior to obtaining
             pharmacokinetic samples. Ratings may be completed via telephone on day-1.

          6. Parents or guardians of patients must have the ability to read and understand the
             language in which the Informed Consent is written and are mentally and physically
             competent to provide written informed consents for their child.

          7. Patient and/or parent are/is able to understand English in order to provide assent and
             is otherwise able to comply with the study protocol.

        Exclusion Criteria:

          1. Patient has allergy to methylphenidate or amphetamines, or history of serious adverse
             reaction to methylphenidate.

          2. Patient has a history of tension, agitation, glaucoma, thyrotoxicosis,
             tachyarrhythmias or severe angina pectoris or patient with serious or unstable medical
             illness such as asthma, diabetes or seizures.

          3. A history of motor or vocal tics or Tourette's syndrome

          4. Patient is receiving monoamine oxidase inhibitors, anticonvulsants (phenobarbital,
             phenytoin, primidone), coumarin anticoagulants, presser agents, guanethidine,
             tricyclic antidepressants (imipramine, desipramine, selective serotonin inhibitors
             (SSRIs), or herbal remedies (e.g., melatonin).

          5. Patient has serious hypertension.

          6. Patient has a history of disorders of the sensory organs, particularly deafness,
             severe or profound retardation.

          7. Patient has any other unstable psychiatric condition requiring treatment.

          8. Patient is at risk for substance abuse.

          9. Evidence of current physical, sexual, or emotional abuse

         10. Living with anyone who currently abuses stimulants or cocaine

         11. History of bipolar disorder in both biological parents