Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder.
OBJECTIVE
The efficacy of atomoxetine was assessed in school-age girls with attention-deficit/hyperactivity disorder (ADHD). Atomoxetine is a potent inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors.


METHODS
A total of 291 children who were 7 to 13 years of age and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD participated in 1 of 2 combined, double-blind, placebo-controlled, multisite, identical clinical trials. This intent-to-treat subset analysis examined the effects of atomoxetine versus placebo in 51 girls who were randomized to atomoxetine (n = 30) or placebo (n = 21) for 9 weeks. ADHD symptoms were assessed using parent- and investigator-rated scales.


RESULTS
Atomoxetine was superior to placebo on the following measures: the Attention-Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored Total Score; the Inattentive and Hyperactive/Impulsive subscales of the Attention-Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored Total Score; the ADHD Index subscale of the Conners' Parent Rating Scale-Revised: Short Form; and the Clinical Global Impressions of Severity of ADHD. Statistically significant efficacy was seen 1 week after randomization and remained so for the duration of the study. One patient from each of the atomoxetine and placebo groups discontinued the study as a result of an adverse event.


CONCLUSIONS
Atomoxetine was found to be effective and well tolerated for the treatment of ADHD in school-age girls.
Biederman
Joseph
J
Massachusetts General Hospital, Boston, Massachusetts, USA.
Heiligenstein
John H
JH
Faries
Douglas E
DE
Galil
Nora
N
Dittmann
Ralf
R
Emslie
Graham J
GJ
Kratochvil
Christopher J
CJ
Laws
Harry F
HF
Schuh
Kory J
KJ
D000293:Adolescent; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000009:adverse effects / Q000627:therapeutic use*; D012737:Sex Factors; D016896:Treatment Outcome
D011437:Propylamines; D000069445:Atomoxetine Hydrochloride