Conditions: Attention Deficit Hyperactivity Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 399
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

Detailed description:

Arms:
arm 1: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension arm 2: Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Interventions: intervention 1: Atomoxetine intervention 2: Other standard therapy for ADHD
Intervention descriptions: intervention 1: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension intervention 2: Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Protocol document: