ATOMOXETINE TREATMENT FOR PEDIATRIC PATIENTS WITH ADHD AND COMORBID ANXIETY

Objectives: Research indicates 25%-50% comorbidity of anxiety disorders with attention-deficit/hyperactivity disorder (ADHD). Atomoxetine is a nonstimulant approved for treating ADHD that is not contraindicated in the presence of anxiety disorders. This study compared atomoxetine with placebo in treating pediatric patients with ADHD and comorbid anxiety, as measured by the ADHDRS-IV-Parent: Inv (ADHDRS) Total Score and the Pediatric Anxiety Rating Scale (PARS) Total Score. Methods: Patients in this double-blind, acute portion of an extended, multicenter trial were randomly assigned to approximately 12 weeks of atomoxetine treatment (n=87) or placebo (n=89). Patients met DSM-IV criteria for both ADHD and anxiety disorder (generalized anxiety, separation anxiety, or social phobia). ADHD RS and PARS total scores were analyzed using ANCOVA (LOCF). Patients who responded during a placebo lead-in period were excluded from ADHD RS and PARS (total scores) analyses. Results: Mean ADHD RS total score improved significantly from baseline to endpoint for the atomoxetine group (n=55; -10.5, SD 10.6) relative to placebo (n=58; -1.4, SD 8.3; P<.001). Mean PARS total score also improved significantly from baseline to endpoint for the atomoxetine group (n=55; -5.5, SD 4.8) relative to placebo (n=58; -3.2, SD 5.0; P=0.011). Conclusion: Results suggest atomoxetine is efficacious in pediatric patients with ADHD and comorbid anxiety.