Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders.
OBJECTIVE
To test the hypothesis that atomoxetine does not significantly worsen tic severity relative to placebo in children and adolescents with attention deficit/hyperactivity disorder (ADHD) and comorbid tic disorders.


METHODS
Study subjects were 7 to 17 years old, met Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ADHD, and had concurrent Tourette syndrome or chronic motor tic disorder. Patients were randomly assigned to double-blind treatment with placebo (n = 72) or atomoxetine (0.5 to 1.5 mg/kg/day, n = 76) for up to 18 weeks.


RESULTS
Atomoxetine treatment was associated with greater reduction of tic severity at endpoint relative to placebo, approaching significance on the Yale Global Tic Severity Scale total score (-5.5 +/- 6.9 vs -3.0 +/- 8.7, p = 0.063) and Tic Symptom Self-Report total score (-4.7 +/- 6.5 vs -2.9 +/- 5.2, p = 0.095) and achieving significance on the Clinical Global Impressions (CGI) tic/neurologic severity scale score (-0.7 +/- 1.2 vs -0.1 +/- 1.0, p = 0.002). Atomoxetine patients also showed greater improvement on the ADHD Rating Scale total score (-10.9 +/- 10.9 vs -4.9 +/- 10.3, p < 0.001) and CGI severity of ADHD/psychiatric symptoms scale score (-0.8 +/- 1.1 vs -0.3 +/- 1.0, p = 0.015). Discontinuation rates were not significantly different between treatment groups. Atomoxetine patients had greater increases in heart rate and decreases of body weight, and rates of treatment-emergent decreased appetite and nausea were higher. No other clinically relevant treatment differences were seen in any other vital sign, adverse event, or electrocardiographic or laboratory measures.


CONCLUSIONS
Atomoxetine did not exacerbate tic symptoms. Rather, there was some evidence of reduction in tic severity with a significant reduction of attention deficit/hyperactivity disorder symptoms. Atomoxetine treatment appeared safe and well tolerated.
Allen
A J
AJ
Lilly Research Laboratories, Indianapolis, IN 46285, USA. allenaj@lilly.com
Kurlan
R M
RM
Gilbert
D L
DL
Coffey
B J
BJ
Linder
S L
SL
Lewis
D W
DW
Winner
P K
PK
Dunn
D W
DW
Dure
L S
LS
Sallee
F R
FR
Milton
D R
DR
Mintz
M I
MI
Ricardi
R K
RK
Erenberg
G
G
Layton
L L
LL
Feldman
P D
PD
Kelsey
D K
DK
Spencer
T J
TJ
D000293:Adolescent; D000322:Adrenergic Agonists / Q000008:administration & dosage / Q000009:adverse effects; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D001835:Body Weight / Q000187:drug effects; D002648:Child; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D015990:Placebo Effect; D011437:Propylamines / Q000008:administration & dosage* / Q000009:adverse effects; D013610:Tachycardia / Q000139:chemically induced; D013981:Tic Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
D000322:Adrenergic Agonists; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride