Efficacy and safety of atomoxetine in childhood Attention-Deficit/Hyperactivity Disorder with comorbid Oppositional Defiant Disorder

• Published in: Journal of attention disorders Vol. 8; no. 2; pp. 45 - 52
• Main Authors: Kaplan, S., Heiligenstein, J., West, S., Busner, J., Harder, D., Dittmann, R., Casat, C., Wernicke, J. F.
• Format: Journal Article
• Language: English
• Published: Thousand Oaks, CA Sage Publications 01.10.2004; SAGE Publications
• Subjects: Adolescent; Atomoxetine Hydrochloride; Attention Deficit and Disruptive Behavior Disorders - complications; Attention Deficit and Disruptive Behavior Disorders - drug therapy; Attention Deficit Disorder with Hyperactivity - complications; Attention Deficit Disorder with Hyperactivity - diagnosis; Attention Deficit Disorder with Hyperactivity - drug therapy; Attention Deficit Disorders; Behavior Disorders; Child; Child Behavior; Children; Conners Rating Scales; Diagnostic and Statistical Manual of Mental Disorders; Diagnostic Interview for Children and Adolescents; Double-Blind Method; Drug Therapy; Early Adolescents; Female; Humans; Hyperactivity; Male; Neuropsychological Tests; Norepinephrine - metabolism; Outcomes of Treatment; Parents; Patients; Propylamines - adverse effects; Propylamines - pharmacology; Propylamines - therapeutic use; Rating Scales; Safety; Severity (of Disability); Single-Blind Method; Symptoms (Individual Disorders)
• ISSN: 1087-0547; 1557-1246
• DOI: 10.1177/108705470400800202

Objective: To compare the safety and efficacy of atomoxetine, a selective inhibitor of the norepinephrine transporter, versus placebo in Attention-Deficit/Hyperactivity Disorder (ADHD) patients with comorbid Oppositional Defiant Disorder (ODD). Methods: A subset analysis of 98 children from two identical, multi-site, double-blind, randomized, placebo-controlled trials involving 9 weeks of treatment with atomoxetine or placebo was conducted. Patients met DSM-IV ADHD criteria. ODD was diagnosed with the Diagnostic Interview for Children and Adolescents-IV (DICA-IV; Reich, Welner, & Herjanic, 1997). ADHD severity was assessed with the ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHD-RS-IV-Parent:Inv; DuPaul, Power, Anastopoulos, & Reid, 1998); the short version of the Conners’ Parent Rating Scales-Revised (CPRS-R:S; Conners, 2000); and the Clinical Global Impressions of ADHD Severity (CGI-ADHD-S; Guy, 1976). Clinical response was defined as a ≥ 25% reduction in ADHD-RS-IV-Parent:Inv total score. Results: ADHD-RS-IV-Parent:Inv, CGI-ADHD-S, and three CPRS-R:S subscale scores improved markedly with atomoxetine treatment. However, a decrease in the CPRS-R:S Oppositional subscore for atomoxetine-treated patients was not significantly greater than scores for placebo-treated patients. Clinical response rates were 65.4% in the atomoxetine group, and 36.4% in the placebo group (p = .007). Conclusion: Atomoxetine was effective for the treatment of ADHD in patients with comorbid ODD. It did not significantly reduce the severity of ODD symptoms, and was well tolerated by the patients.