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A randomized, double-blind, placebo-controlled study of atomoxetine in Japanese children and adolescents with attention-deficit/hyperactivity disorder.
- Source :
-
Journal of child and adolescent psychopharmacology [J Child Adolesc Psychopharmacol] 2009 Aug; Vol. 19 (4), pp. 341-50. - Publication Year :
- 2009
-
Abstract
- Objectives: Until the recent approval of methylphenidate (MPH), Japan had no approved treatment for attention-deficit/hyperactivity disorder (ADHD). The need still exists for an effective, safe, nonstimulant treatment. This first placebo-controlled Japan study of an ADHD nonstimulant therapy assessed atomoxetine efficacy and safety to determine the optimal dose for controlling ADHD symptoms in children and adolescents.<br />Methods: A total of 245 Japanese children and adolescents, aged 6-17 years and diagnosed with ADHD, were randomly assigned to receive placebo or one of three atomoxetine doses (0.5, 1.2, and 1.8 mg/kg per day) over 8 weeks. Symptoms were assessed with the Japanese Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator scored and integrated with teacher reports (ADHD RS-IV-J:I/Sch). Adverse events, vital signs, laboratory tests, and electrocardiograms (ECGs) were obtained for safety analysis.<br />Results: In all, 234 patients completed the study. Atomoxetine at 1.8 mg/kg per day was significantly superior to placebo in reducing ADHD symptoms (p = 0.01; one-sided). Decreased appetite and vomiting were significantly greater in the atomoxetine treatment groups; however, no clinically significant differences were observed. Two patients discontinued due to affect lability and headache. A linear dose-response and vital signs similar to those from other atomoxetine studies were observed.<br />Conclusion: Atomoxetine provides an effective and safe nonstimulant option for the treatment of Japanese pediatric patients with ADHD.
- Subjects :
- Adolescent
Age Factors
Atomoxetine Hydrochloride
Attention Deficit Disorder with Hyperactivity psychology
Child
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Male
Asian People psychology
Attention Deficit Disorder with Hyperactivity drug therapy
Attention Deficit Disorder with Hyperactivity epidemiology
Propylamines therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1557-8992
- Volume :
- 19
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of child and adolescent psychopharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 19702486
- Full Text :
- https://doi.org/10.1089/cap.2008.0154