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.
