A randomized, placebo-controlled study of once-daily atomoxetine in the school setting in children with ADHD.
OBJECTIVE
Five studies have demonstrated the effectiveness of atomoxetine compared with placebo in reducing symptoms of attention-deficit/hyperactivity disorder (ADHD) based on parent reports. The primary objective of this clinical trial was to assess the efficacy of once-daily atomoxetine compared with placebo using teacher reports.


METHODS
One hundred fifty-three patients aged 8-12 years were randomly assigned to receive once-daily atomoxetine or placebo in a 2:1 ratio for 7 weeks. ADHD symptoms at school were primarily assessed by baseline-to-endpoint change on the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Teacher Version: Investigator administered and scored (ADHDRS-IV-Teacher:Inv) as rated by investigators using teacher reports.


RESULTS
ADHDRS-IV-Teacher:Inv total scores were significantly lower for children treated with atomoxetine compared with those treated with placebo (p = .001). Similar results were observed for the inattentive (p = .016) and hyperactive/impulsive (p < .001) ADHDRS-IV-Teacher:Inv subscales, the clinician-rated Clinical Global Impressions severity scale (p = .001), the Conners Global Index-Teacher scale (p = .008), and the Conners Parent Rating Scale-Revised: Short Form ADHD Index T-Score (p < .001). Discontinuations due to adverse events were low in both groups (atomoxetine 5.9%, placebo 0%, p = .096).


CONCLUSIONS
This study extends previous results based on parent reports showing that once-daily administration of atomoxetine is safe and effective in improving ADHD symptoms in children and demonstrates that outcomes at school are similar when symptoms are reported by teachers.
Weiss
Margaret
M
University of British Columbia, Vancouver, Canada.
Tannock
Rosemary
R
Kratochvil
Christopher
C
Dunn
David
D
Velez-Borras
Jesus
J
Thomason
Christine
C
Tamura
Roy
R
Kelsey
Douglas
D
Stevens
Linda
L
Allen
Albert J
AJ
D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000008:administration & dosage / Q000627:therapeutic use*; D012574:Schools; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index
D000069445:Atomoxetine Hydrochloride; D011437:Propylamines; D017367:Selective Serotonin Reuptake Inhibitors