Conditions: Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 139
Healthy volunteers: no

Brief summary:
The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD). The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and ODD symptoms in patients non responders to a previous psychological intervention with parent support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid conditions associated with ADHD and ODD will be assessed.

Detailed description:

Arms:
arm 1: atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval. arm 2: placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval.

Interventions: intervention 1: atomoxetine 0.5 mg/kg/day intervention 2: placebo intervention 3: atomoxetine 1.2 mg/kg/day intervention 4: atomoxetine 1.2-1.4 mg/kg/day
Intervention descriptions: intervention 1: atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) intervention 2: None intervention 3: atomoxetine 1.2 mg/kg/day QD, PO intervention 4: atomoxetine 1.2 - 1.4 mg/kg/day QD, PO

Protocol document: