A randomized, double-blind, placebo-controlled study of atomoxetine in Japanese children and adolescents with attention-deficit/hyperactivity disorder.
OBJECTIVE
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.


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.


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.


CONCLUSIONS
Atomoxetine provides an effective and safe nonstimulant option for the treatment of Japanese pediatric patients with ADHD.
Takahashi
Michihiro
M
Lilly Research Laboratories Japan , Kobe, Japan. E-mail: takahashi_michihiro@lilly.com
Takita
Yasushi
Y
Yamazaki
Kosuke
K
Hayashi
Takashi
T
Ichikawa
Hironobu
H
Kambayashi
Yasuko
Y
Koeda
Tatsuya
T
Oki
Junichi
J
Saito
Kazuhiko
K
Takeshita
Kenzo
K
Allen
Albert J
AJ
D000293:Adolescent; D000367:Age Factors; D044466:Asian People / Q000523:psychology; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000453:epidemiology* / Q000523:psychology; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000627:therapeutic use*
D011437:Propylamines; D000069445:Atomoxetine Hydrochloride