drugset / Trial / 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).
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2004-10
- Primary completion
- 2006-08
- Completion
- 2008-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atomoxetine | Other / unclassified | 0.5 mg/kg | Oral |
| Subject | Atomoxetine | Other / unclassified | 1.2 mg/kg | Oral |
| Subject | Atomoxetine | Other / unclassified | 1.4 mg/kg | Oral |