Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Inclusion Criteria:

• Subjects have primary diagnosis of ADHD
• Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
• Subject has an IQ score of >_ 80
• Subject is able to complete as least the Basic Test of the PERMP assessment

Exclusion Criteria:

• Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
• Subject is taking Strattera(r)
• Subject has a recent history of suspected substance abuse or dependence disorder