A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD.
OBJECTIVE
The aim of this study was to study treatment response to atomoxetine in a large, multicenter study of non-North American patients with ADHD.


METHODS
A total of 604 children and adolescents with ADHD were enrolled in a 10-week open-label trial with atomoxetine prior to randomization to a double-blind relapse prevention phase at 33 sites in the United Kingdom, continental Europe, Israel, South Africa, and Australia. All patients had ADHD symptom severity at least 1.5 standard deviations above United States age and gender norms for their diagnostic subtype as measured by the investigator-scored ADHD Rating Scale (ADHD RS). Outcomes were assessed by analysis of change in the ADHD RS; functional and psychosocial outcomes were assessed using the Child Health Questionnaire (CHQ).


RESULTS
At endpoint, ADHD RS total scores decreased by an average of 56.7%, and 69% of patients were rated as having no or minimal symptoms. Significant improvement was observed in psychosocial and functional outcomes. Discontinuations attributed to adverse events were < 4%.


CONCLUSIONS
These open-label data, gathered in an international setting, add to our knowledge of the value of atomoxetine in treating ADHD symptoms, as well as its safety and tolerability.
Buitelaar
Jan K
JK
Department of Psychiatry, University Medical Center Nijmegen, 9101, 6500, HB Nijmegen, The Netherlands.
Danckaerts
Marina
M
Gillberg
Christopher
C
Zuddas
Alessandro
A
Becker
Katja
K
Bouvard
Manuel
M
Fagan
Jenny
J
Gadoros
Julia
J
Harpin
Valerie
V
Hazell
Philip
P
Johnson
Mats
M
Lerman-Sagie
Tally
T
Soutullo
Cesar A
CA
Wolanczyk
Tomasz
T
Zeiner
Pal
P
Fouche
Daniel S
DS
Krikke-Workel
Judith
J
Zhang
Shuyu
S
Michelson
David
D
D000293:Adolescent; D018663:Adrenergic Agents / Q000627:therapeutic use*; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology*; D002648:Child; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000627:therapeutic use*; D011446:Prospective Studies; D012720:Severity of Illness Index
D018663:Adrenergic Agents; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride