Atomoxetine and methylphenidate treatment in children with ADHD: a prospective, randomized, open-label trial.
OBJECTIVE
To assess the comparability of atomoxetine, a new therapy for attention-deficit/hyperactivity disorder (ADHD) and methylphenidate. (Atomoxetine was originally called tomoxetine. The name was recently changed in order to avoid any potential confusion with tamoxifen that might lead to errors in dispensing drug.)


METHODS
Children with ADHD were randomized to open-label atomoxetine or methylphenidate for 10 weeks. Response was assessed with the ADHD-IV Rating Scale.


RESULTS
Two hundred twenty-eight patients were randomized (atomoxetine n = 184, methylphenidate n = 44). Both drugs were associated with marked improvement in inattentive and hyperactive-impulsive symptom clusters as assessed by parents and investigators. No statistically significant differences between treatment groups were observed on the primary outcome measure (investigator-rated ADHD-IV Rating Scale total score: atomoxetine baseline: 39.4 [8.5], endpoint: 20.0 [13.9]; methylphenidate baseline: 37.6 [9.7], endpoint: 19.8 (16.6); p = .66). Safety and tolerability were also similar between the 2 drugs. Discontinuations due to adverse events were 10/184 (5.4%) for atomoxetine and 5/44 (11.4%) for methylphenidate; p = .175.


CONCLUSIONS
These data provide preliminary evidence that atomoxetine is associated with therapeutic effects comparable to those of methylphenidate.
Kratochvil
Christopher J
CJ
University of Nebraska Medical Center, USA.
Heiligenstein
John H
JH
Dittmann
Ralf
R
Spencer
Thomas J
TJ
Biederman
Joseph
J
Wernicke
Joachim
J
Newcorn
Jeffrey H
JH
Casat
Charles
C
Milton
Denai
D
Michelson
David
D
D000293:Adolescent; D000928:Antidepressive Agents / Q000627:therapeutic use*; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D011437:Propylamines / Q000627:therapeutic use*; D011446:Prospective Studies
D000928:Antidepressive Agents; D000697:Central Nervous System Stimulants; D011437:Propylamines; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride