NCT00320528

Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder With or Without Comorbid Conditions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	atomoxetine	0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-05-03
• Last updated: 2010-01-06
• Results posted: 2010-01-06

Locations

20 sites across 1 country: Italy