Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD

A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD

Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD

Inclusion Criteria:

• Primary diagnosis ADHD
• Total score of greater than or equal to 26 on ADHD-RS-IV
• IQ of greater than or equal to 80
• Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline

Exclusion Criteria:

• Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
• Known nonresponder to psychostimulant treatment
• BMI for age greater than 90th percentile
• History of seizures during last 2 years
• Conduct Disorder