ABSTRACT
OBJECTIVE: To evaluate the efficacy and tolerability of atomoxetine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in 5- and 6-year-old children. METHODS: This was an 8-week, double-blind, placebo-controlled randomized clinical trial of atomoxetine in 101 children with ADHD. Atomoxetine or placebo was flexibly titrated to a maximum dose of 1.8 mg/kg per day. The pharmacotherapist reviewed psychoeducational material on ADHD and behavioral-management strategies with parents during each study visit. RESULTS: Significant mean decreases in parent (P = .009) and teacher (P = .02) ADHD-IV Rating Scale scores were demonstrated with atomoxetine compared with placebo. A total of 40% of children treated with atomoxetine met response criteria (Clinical Global Impression-Improvement Scale indicating much or very much improved) compared with 22% of children on placebo, which was not significant (P = .1). Decreased appetite, gastrointestinal upset, and sedation were significantly more common with atomoxetine than placebo. Although some children demonstrated a robust response to atomoxetine, for others the response was more attenuated. Sixty-two percent of subjects who received atomoxetine were moderately, markedly, or severely ill according to the Clinical Global Impression-Severity Scale at study completion. CONCLUSIONS: To our knowledge, this is the first randomized controlled trial of atomoxetine in children as young as 5 years. Atomoxetine generally was well tolerated and reduced core ADHD symptoms in the children on the basis of parent and teacher reports. Reductions in the ADHD-IV Rating Scale scores, however, did not necessarily translate to overall clinical and functional improvement, as demonstrated on the Clinical Global Impression-Severity Scale and the Clinical Global Impression-Improvement Scale. Despite benefits, the children in the atomoxetine group remained, on average, significantly impaired at the end of the study.
Subject(s)
Attention Deficit Disorder with Hyperactivity/drug therapy , Central Nervous System Stimulants/therapeutic use , Propylamines/therapeutic use , Age Factors , Atomoxetine Hydrochloride , Attention Deficit Disorder with Hyperactivity/diagnosis , Attention Deficit Disorder with Hyperactivity/psychology , Central Nervous System Stimulants/adverse effects , Child , Child, Preschool , Combined Modality Therapy , Dose-Response Relationship, Drug , Double-Blind Method , Education , Female , Humans , Male , Off-Label Use , Personality Assessment/statistics & numerical data , Propylamines/adverse effects , PsychometricsSubject(s)
Attention Deficit Disorder with Hyperactivity/drug therapy , Central Nervous System Stimulants/therapeutic use , Adolescent , Adrenergic alpha-Agonists/adverse effects , Adrenergic alpha-Agonists/economics , Adrenergic alpha-Agonists/therapeutic use , Atomoxetine Hydrochloride , Attention Deficit Disorder with Hyperactivity/diagnosis , Attention Deficit Disorder with Hyperactivity/psychology , Bupropion/adverse effects , Bupropion/economics , Bupropion/therapeutic use , Central Nervous System Stimulants/adverse effects , Central Nervous System Stimulants/economics , Child , Delayed-Action Preparations , Dose-Response Relationship, Drug , Drug Administration Routes , Drug Costs/statistics & numerical data , Humans , Propylamines/adverse effects , Propylamines/economics , Propylamines/therapeutic use , Treatment Outcome , United States , United States Food and Drug AdministrationABSTRACT
Atomoxetine (Strattera, Eli Lilly & Co.) is a highly selective noradrenaline reuptake inhibitor and the first nonstimulant medication to be approved for the treatment of attention deficit hyperactivity disorder. Currently, nine published clinical trials have documented the safety and efficacy of atomoxetine in the treatment of children, adolescents and adults with attention deficit hyperactivity disorder and data presented throughout the past year at national scientific meetings has further addressed its utility. This article reviews the available information on atomoxetine, accompanied by a discussion of its clinical use.
