NCT00406354

Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany

A Randomized, Double-Blind Comparison of Atomoxetine Versus Placebo in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an initial 3- to 28-day screening and washout phase, participants will be assigned to double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.

Conditions

• Attention Deficit Hyperactivity Disorder
• Oppositional Defiant Disorder

Interventions

Type	Name	Description
DRUG	Atomoxetine	Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks.
DRUG	Placebo	Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2006-12-04
• Last updated: 2010-02-26
• Results posted: 2010-02-12

Locations

6 sites across 1 country: Germany