Atomoxetine and osmotically released methylphenidate for the treatment of attention deficit hyperactivity disorder: acute comparison and differential response.
OBJECTIVE
Response to atomoxetine, a nonstimulant norepinephrine-specific reuptake inhibitor, was compared with the effect of osmotic-release oral methylphenidate, a long-acting methylphenidate preparation, in patients with attention deficit hyperactivity disorder (ADHD).


METHODS
In a large placebo-controlled, double-blind study, patients ages 6-16 with ADHD, any subtype, were randomly assigned to receive 0.8-1.8 mg/kg per day of atomoxetine (N=222), 18-54 mg/day of osmotically released methylphenidate (N=220), or placebo (N=74) for 6 weeks. The a priori specified primary analysis compared response (at least 40% decrease in ADHD Rating Scale total score) to osmotically released methylphenidate with response to atomoxetine and placebo. After 6 weeks, patients treated with methylphenidate were switched to atomoxetine under double-blind conditions.


RESULTS
The response rates for both atomoxetine (45%) and methylphenidate (56%) were markedly superior to that for placebo (24%), but the response to osmotically released methylphenidate was superior to that for atomoxetine. Each medication was well tolerated, with completion rates and discontinuations for adverse events not significantly different from those for placebo. Of the 70 subjects who did not respond to methylphenidate, 30 (43%) subsequently responded to atomoxetine. Likewise, 29 (42%) of the 69 patients who did not respond to atomoxetine had previously responded to osmotically released methylphenidate.


CONCLUSIONS
Response was significantly greater with osmotically released methylphenidate than with atomoxetine. One-third of patients who received methylphenidate followed by atomoxetine responded better to one or the other, suggesting that there may be preferential responders.
Newcorn
Jeffrey H
JH
Department of Psychiatry, Mount Sinai Medical Center, Box 1230, One Gustave L. Levy Place, New York, NY 10029, USA. Jeffrey.Newcorn@mssm.edu
Kratochvil
Christopher J
CJ
Allen
Albert J
AJ
Casat
Charles D
CD
Ruff
Dustin D
DD
Moore
Rodney J
RJ
Michelson
David
D
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000069445:Atomoxetine Hydrochloride; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects; D010552:Personality Assessment; D011437:Propylamines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D011437:Propylamines; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride