A randomized, double-blind study of continuation treatment for attention-deficit/hyperactivity disorder after 1 year.
BACKGROUND
The efficacy of atomoxetine in maintaining symptom response following 1 year of treatment was assessed in children and adolescents (n = 163) with DSM-IV defined attention-deficit/hyperactivity disorder (ADHD).


METHODS
Subjects had previously responded to atomoxetine acutely and had completed 1 year of double-blind atomoxetine treatment. They were then randomly assigned in double-blind fashion to continued atomoxetine or placebo substitution for 6 months.


RESULTS
Atomoxetine was superior to placebo in preventing relapse (Wilcoxon test, p = .008) and in maintaining symptom response (ADHD Rating Scale IV score, p < .001). Among subjects assigned to discontinuation, the magnitude of symptom return was generally to a level of severity less than that observed at study entry.


CONCLUSIONS
Following 1 year of treatment with atomoxetine, continued treatment over the ensuing 6 months was associated with superior outcomes compared with placebo substitution. However, there was considerable variability between individuals in the magnitude of symptom return after drug discontinuation, suggesting that some subjects treated with atomoxetine for a year with good results may consolidate gains made during drug treatment and could benefit from a medication-free trial to assess the need for ongoing drug treatment.
Buitelaar
Jan K
JK
University Medical Center St Radboud, Nijmegen, The Netherlands.
Michelson
David
D
Danckaerts
Marina
M
Gillberg
Christopher
C
Spencer
Thomas J
TJ
Zuddas
Alessandro
A
Faries
Douglas E
DE
Zhang
Shuyu
S
Biederman
Joseph
J
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011437:Propylamines / Q000627:therapeutic use*; D055502:Secondary Prevention; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride