Atomoxetine had no enduring effect on oppositional defiant disorder symptoms in a new report of manufacturer data from children with both ODD and attention-deficit/hyperactivity disorder.
The findings from the 8-week, multicenter, placebo-controlled trial run counter to the results of a previous study that suggested atomoxetine (Strattera) could improve symptoms in patients with both disorders. Atomoxetine, a norepinephrine reuptake inhibitor, was approved in 2002 as the first nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). ODD is thought to be present in 40%–60% of children with ADHD.
In the study, 156 children with both disorders received 1.2 mg/kg per day of atomoxetine for 8 weeks, and 70 received placebo. The subjects, aged 6–12 years, came from 17 centers in Europe. Improvement was measured on the Swanson, Nolan, and Pelham Rating Scale-Revised, which has 18 items used to grade ADHD symptoms and 8 used to grade ODD symptoms.
ADHD symptoms were significantly improved on the rating scale, but ODD symptoms were no better at week 8. Although those given the active treatment had improved ratings relative to placebo-treated children at weeks 2 and 5 of the trial, “it remains uncertain whether atomoxetine exerts a specific and enduring effect on ODD symptoms,” said Dr. Mark E. Bangs of Lilly Research Laboratories, Indianapolis, and his colleagues in the Atomoxetine ADHD/ODD Study Group (Pediatrics 2008;121:e314–20).
“Patients with ADHD and ODD will not be disadvantaged by treatment with atomoxetine, but additional pharmacologic or psychological strategies may be needed to address the ODD symptoms, they said. Dr. Bangs and several of his coinvestigators are employees and shareholders of Eli Lilly & Co., which funded the study and manufactures Strattera.