Neuropediatrics 2006; 37 - TP75
DOI: 10.1055/s-2006-945668

LONG-TERM ATOMOXETINE ADMINISTRATION FOR YOUNG CHILDREN WITH ATTENTION-DEFICIT/HYPERACTIVITY DISORDER

C Kratochvil 1, T Wilens 2, L Greenhill 3, H Gao 4, C Thomason 4, R Dickson 5, D Gelowitz 4
  • 1University of Nebraska Medical Center, Omaha, NE, United States
  • 2Massachusetts General Hospital, Boston, MA, United States
  • 3New York State Psychiatric Institute, New York, NY, United States
  • 4Lilly Research Laboratories, Indianapolis, IN, United States
  • 5Eli Lilly Canada, Toronto, ON, Canada

Objectives: The purpose of this presentation is to report on the efficacy and tolerability of long-term atomoxetine treatment among young children with attentiondeficit/ hyperactivity disorder (ADHD).

Methods: Data from 6- and 7-year old children (n=192) enrolled in similarly designed clinical trials that met DSM-IV criteria for ADHD were pooled. The children had a minimum of 12 months of atomoxetine treatment and 97 (51%) receive treatment for >24 months. The mean modal dose (SD) of atomoxetine was 1.55mg/kg/day (0.32). The primary efficacy outcome measure was the mean change from baseline to endpoint in the ADHD Rating Scale-IV (ADHD RS). The Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) was a secondary efficacy measure.

Results: Significant mean treatment effects from baseline to endpoint for ADHD RS and CPRS-R:S scores were observed (P<.001). The effectiveness of atomoxetine treatment for children was maintained over long-term treatment as demonstrated by ADHD RS total and T-scores. Adverse events were clinically minor and transient, and only 1.6% of children discontinued due to adverse events. There were no clinically meaningful changes in laboratory tests. Also, further follow-up and analyses are ongoing.

Conclusion: Long-term atomoxetine treatment appears to be well-tolerated and effective in young children with ADHD.