NCT00192023

An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).

An Italian Randomised, Double-blind Placebo Controlled Study of the Efficacy of Atomoxetine Hydrochloride in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder
• Oppositional Defiant Disorder

Interventions

Type	Name	Description
DRUG	atomoxetine 0.5 mg/kg/day	atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO)
DRUG	placebo
DRUG	atomoxetine 1.2 mg/kg/day	atomoxetine 1.2 mg/kg/day QD, PO
DRUG	atomoxetine 1.2-1.4 mg/kg/day	atomoxetine 1.2 - 1.4 mg/kg/day QD, PO

Timeline

• Start date: 2004-10-01
• Primary completion: 2006-08-01
• Completion: 2008-05-01
• First posted: 2005-09-19
• Last updated: 2010-01-18
• Results posted: 2010-01-18

Locations

12 sites across 1 country: Italy