Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)

A Phase III, Randomized, Multicenter, Double-blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With ADHD

Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg).

Inclusion Criteria:

• Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD

Exclusion Criteria:

• Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD
• Known non-responder to stimulant medication
• Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines
• Conduct Disorder, hypertension, history of seizure
• Tic disorder or Tourette's disorder