At a glance
ClinicalIndex Comparison Record- ✓Age 6 to <16 years (outpatients)
- ✓Meet DSM-IV criteria for ADHD (any subtype) and ODD
- ✓SNAP-IV ADHD subscale score at least 1.5 SD above age norm at both Visit 1 and Visit 2
- ✓SNAP-IV ODD subscale score ≥15 at both Visit 1 and Visit 2
- ✕Weight <20 kg at baseline (Visit 1)
- ✕History of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
- ✕History of seizure disorder (except febrile seizures) or current/prior anticonvulsant use for seizure control
- ✕Serious suicidal risk per investigator assessment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating atomoxetine 0.5 mg/kg/day, placebo, and 2 other interventions for Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder. Completed, enrolled 139 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO)
atomoxetine 1.2 mg/kg/day QD, PO
atomoxetine 1.2 - 1.4 mg/kg/day QD, PO