Published online February 1, 2008
PEDIATRICS Vol. 121 No. 2 February 2008, pp. e314-e320 (doi:10.1542/peds.2006-1880)
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ARTICLE

Atomoxetine for the Treatment of Attention-Deficit/Hyperactivity Disorder and Oppositional Defiant Disorder

Mark E. Bangs, MDa, Philip Hazell, PhD, FRANZCPb, Marina Danckaerts, MD, PhDc, Peter Hoare, DM, FRC, Psychd, David R. Coghill, MBChB, MDe, Peter M. Wehmeier, MDf, David W. Williams, MSa, Rodney J. Moore, PhDa, Louise Levine, MDa for the Atomoxetine ADHD/ODD Study Group

a Lilly Research Laboratories, Indianapolis, Indiana
b Child and Adolescent Mental Health Services, University of Newcastle, Newcastle, Australia
c Division of Psychiatry, University of Ziekenhuis Gasthuisberg Leuven, Leuven, Belgium
d Child and Family Health Service, University of Edinburgh, Edinburgh, United Kingdom
e Section of Psychiatry, Division of Pathology and Neuroscience, University of Dundee, Dundee, Scotland, United Kingdom
f Lilly Deutschland, Bad Homburg, Germany

OBJECTIVE. In this study we examined the effectiveness of atomoxetine for the treatment of oppositional defiant disorder comorbid with attention-deficit/hyperactivity disorder.

METHODS. Patients were aged 6 to 12 years and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnostic criteria for attention-deficit/hyperactivity disorder with a Swanson, Nolan, and Pelham Rating Scale-Revised attention-deficit/hyperactivity disorder subscale score above age and gender norms; Clinical Global Impressions-Severity Scale score of ≥4; and Swanson, Nolan, and Pelham Rating Scale-Revised oppositional defiant disorder subscale score of ≥15. Patients were randomly assigned in a 2:1 ratio to receive 1.2 mg/kg per day of atomoxetine (n = 156) or placebo (n = 70) for 8 weeks. Treatment effect on oppositional defiant disorder and attention-deficit/hyperactivity disorder symptoms was measured by using the investigator-rated Swanson, Nolan, and Pelham Rating Scale-Revised.

RESULTS. Repeated-measures analysis demonstrated a statistically significant difference favoring atomoxetine over placebo in the reduction of Swanson, Nolan, and Pelham Rating Scale-Revised oppositional defiant disorder total scores. There were significant pairwise treatment differences at weeks 2 and 5 but not at week 8 postbaseline. A last-observation-carried-forward analysis showed Swanson, Nolan, and Pelham Rating Scale-Revised scores at endpoint for the atomoxetine and placebo groups were significantly different for attention-deficit/hyperactivity disorder symptoms but not for oppositional defiant disorder symptoms. Atomoxetine was superior to placebo in a last-observation-carried-forward analysis of Clinical Global Impression-Improvement and Clinical Global Impression-Severity scores.

CONCLUSIONS. This study confirms previous findings that patients with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder show statistically and clinically significant improvement in attention-deficit/hyperactivity disorder symptoms and global clinical functioning when treated with atomoxetine. It remains uncertain, however, whether atomoxetine exerts a specific and enduring effect on oppositional defiant disorder symptoms.

Key Words: ADHD • adolescents • atomoxetine

Abbreviations: ODD—oppositional defiant disorder • ADHD—attention-deficit/hyperactivity disorder • DSM-IV—Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition • SNAP-IV—Swanson, Nolan, and Pelham Rating Scale-Revised • CGI-S—Clinical Global Impressions-Severity Scale • CGI-I—Clinical Global Impressions-Improvement Scale • CGI-P—Conners' Global Index-Parent Version • AIM—Attention-Deficit/Hyperactivity Disorder Impact Module • atomoxetine 1.2—atomoxetine at 1.2 mg/kg per day • atomoxetine 2.4—atomoxetine at 2.4 mg/kg per day • ANCOVA—analysis of covariance • LOCF—last-observation-carried-forward

Accepted Feb 23, 2007.


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