A Study in Attention Deficit Hyperactivity Disorder in Children and Adolescents
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine; Osmotic-release oral system methylphenidate; Placebo
Intervention description: 25-80 milligrams (mg) administered orally, once daily.; 18-54 mg administered orally, once daily.; Administered orally, once daily for random nonconsecutive 6 days during 4-week treatment period.
Intervention MeSH terms: Methylphenidate; Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The main purpose of the study is to help to understand the effect on children and adolescents
      who are stable on treatment with atomoxetine or osmotic-release oral system (OROS)
      methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the
      medication for a maximum of 6 days over a 28-day study treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth
             Edition Text Revision (DSM-IV-TR) diagnostic criteria for
             attention-deficit/hyperactivity disorder (ADHD), confirmed at screening by
             administering the Kiddie Schedule for Affective Disorders and Schizophrenia for School
             Aged Children-Present and Lifetime Version.

          -  Patients must have an Attention-Deficit/Hyperactivity Disorder Rating Scale - IV -
             Parent Version: Investigator Administered and Scored, total score of less than or
             equal to 20 at screening and baseline.

          -  Patients must have a Clinical Global Impression-Attention-Deficit/Hyperactivity
             Disorder-Improvement score of 1 ("very much better") or 2 ("much better") at screening
             and baseline.

          -  Patients must have been taking either atomoxetine or osmotic-release oral system
             methylphenidate for the treatment of ADHD between 3 and a maximum of 15 months prior
             to screening.

          -  Patients must have been receiving the same dose of atomoxetine or osmotic-release oral
             system methylphenidate as monotherapy in a single daily dose during the 4 weeks prior
             to screening.

          -  For females of child-bearing potential only: Test negative for pregnancy at the time
             of entry based on a urine pregnancy test

          -  Signed informed consent document (ICD)

        Exclusion Criteria:

          -  Patients who weigh less than 20 kilograms (kg) or more than 70 kg at study entry

          -  Documented history of bipolar disorder, any history of psychosis or pervasive
             development disorder.

          -  Patients with a history of any seizure disorder or patients who have taken
             anticonvulsant treatment for seizure control.

          -  Patients at serious suicidal risk.

          -  History of severe allergies to more than one class of medications or have had multiple
             adverse drug reactions.

          -  Patients with acute or unstable medical conditions including cardiovascular disease
             and hypertension.

          -  Patients taking excluded concomitant medications or likely to begin structured
             psychotherapy for ADHD.

          -  Patients who are currently enrolled in, or discontinued within the last 30 days from a
             clinical trial.

          -  Sexually active females who do not use a medically acceptable method of contraception.