Conditions: Attention Deficit Hyperactivity Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1553
Healthy volunteers: no

Brief summary:
To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).

Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.

Detailed description:

Arms:
arm 1: Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted with be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.

Interventions: intervention 1: atomoxetine
Intervention descriptions: intervention 1: 0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years

Protocol document: