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Clinical Pediatrics
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Once-Daily Atomoxetine for Treating Pediatric Attention-Deficit/Hyperactivity Disorder: Comparison of Morning and Evening Dosing

Stan L. Block, MD

Kentucky Pediatric Research, Bardstown, Kentucky, slblock{at}pol.net

Douglas Kelsey, MD, PhD

Lilly USA, LLC, Indianapolis, Indiana

Daniel Coury, MD

Children's Hospital, Pediatric Clinical Trials International, Columbus, Ohio

Donald Lewis, MD

Monarch Research Associates, Norfolk, Virginia

Humberto Quintana, MD

Louisiana State University Health Science Center, New Orleans, Louisiana

Virginia Sutton, PhD

Lilly Research Laboratories, Indianapolis, Indiana

Kory Schuh, PhD

Lilly USA, LLC, Indianapolis, Indiana

Albert J. Allen, MD, PhD

Lilly Research Laboratories, Indianapolis, Indiana

Calvin Sumner, MD

Lilly Research Laboratories, Indianapolis, Indiana

In this 3-arm, randomized, double-blind trial, once-daily morning-dosed atomoxetine, evening-dosed atomoxetine, and placebo were compared for treating pediatric attention-deficit/hyperactivity disorder (ADHD). Patients received morning atomoxetine/evening placebo (n = 102), morning placebo/evening atomoxetine (n = 93), or morning placebo/evening placebo (n = 93) for about 6 weeks. Core symptom efficacy was measured at weeks 0, 1, 3, and 6. Parent assessments of the child’s home behaviors in the evening and early morning were collected daily during the first 2 weeks of treatment. Morning-dosed and evening-dosed atomoxetine significantly decreased core ADHD symptoms relative to placebo and produced symptom improvements that were measured up to 24 hours later. Morning dosing was superior to evening dosing on some efficacy measures. Evening dosing showed greater tolerability with significantly more patients receiving morning atomoxetine reporting at least 1 adverse event than those receiving evening atomoxetine.

Key Words: atomoxetine • ADHD • child • once-daily • duration of effect

This version was published on September 1, 2009

Clinical Pediatrics, Vol. 48, No. 7, 723-733 (2009)
DOI: 10.1177/0009922809335321
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