Neuropediatrics 2006; 37 - TP69
DOI: 10.1055/s-2006-945662

ATOMOXETINE IN ADOLESCENTS WITH ADHD AND COMORBID DEPRESSION

GJ Emslie 1, ME Bangs 2, T Spencer 3, JL Ramsey 2, HC Detke 2, AK Rogers 2, AJ Allen 2, C Sumner 2
  • 1University of Texas Southwestern Medical Center, Dallas, TX, United States
  • 2Lilly Research Laboratories, Indianapolis, IN, United States
  • 3Massachusetts General Hospital, Boston, MA, United States

Objective: Recent attention has focused on the safety of drugs labeled for the treatment of depression in pediatric patients. Because attention-deficit/hyperactivity disorder (ADHD) may co-occur with depression, we examined the efficacy and safety of atomoxetine, a norepinephrine reuptake inhibitor, in adolescents with ADHD and comorbid depression.

Methods: Patients aged 12 to 17 with confirmed diagnoses of ADHD (ADHD RS ≥1.5 SD above the norm) and comorbid depression (CDRS ≥40) were randomly assigned to atomoxetine (ATX; n=72) or placebo (PBO; n=70) for 9 weeks. Treatment-emergent mania was defined as a Young Mania Rating Scale total score ≥15 postbaseline if baseline was <15.

Results: Mean ADHD RS total score decreased significantly for the atomoxetine group (-13.3, SD 10.0) relative to placebo (-5.1, SD 9.9; P<.001). Mean CDRS improved for all patients but did not differ between groups (ATX -14.8, SD 13.3; PBO –12.8, SD 10.4; P=0.34). Treatment-emergent mania did not differ between groups (ATX 2.9%, PBO 3.0%, P=0.99). Nausea and decreased appetite occurred more frequently in the atomoxetine group. No adverse events involving suicidal ideation or suicidal behavior occurred in either group.

Conclusion: Results suggest that atomoxetine effectively treats ADHD and is safe and tolerable for adolescents with ADHD and comorbid depression.