Atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder: a 6-week, randomized, placebo-controlled, double-blind trial in Russia

Abstract

The objective of the study was to compare the efficacy and tolerability of once-daily atomoxetine (≤1.8 mg/(kg day) with those of placebo in children and adolescents (aged 6–16 years) with attention-deficit/hyperactivity disorder [ADHD (DSM-IV)]. This randomized, placebo-controlled, double-blind trial was conducted in Russia. The primary efficacy measure was baseline-to-end point changes in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) total score. Tolerability measures included treatment-emergent signs and symptoms (TESS), laboratory values and weight. Compared with patients in the placebo group (n = 33), patients treated with atomoxetine (n = 72) with a mean final dose of 1.4 mg/kg showed significantly greater improvement in ADHDRS-IV-Parent:Inv total score (least-squares mean: atomoxetine, –15.8; placebo, –11.4; p = 0.013). The most common TESS in the atomoxetine group included anorexia [atomoxetine, n = 13 (18.1%); placebo, n = 2 (6.1%)], somnolence, n = 11 versus n = 3 (15.3% vs. 9.1%, respectively), abdominal pain n = 9 versus n = 1 (12.5% vs. 3.0%, respectively) and nausea, n = 8 versus n = 1 (11.1% vs. 3.0%, respectively). Seven patients in the atomoxetine group and two in the placebo group experienced clinically important weight loss during the study (≥7% from baseline; mean change, kg: atomoxetine, –0.6; placebo, 0.1; p = 0.032). Atomoxetine is efficacious in improving ADHD symptoms in children and adolescents. Atomoxetine treatment may be associated with a numerically higher incidence of anorexia, somnolence, abdominal pain and nausea, as well as statistically greater losses in body weight.

DOI: 10.1007/s00787-009-0042-7

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@article{Martnyi2009AtomoxetineIC, title={Atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder: a 6-week, randomized, placebo-controlled, double-blind trial in Russia}, author={Ferenc Mart{\'e}nyi and Nikolay N. Zavadenko and Natalia B. Jarkova and Alexandr A. Yarosh and Victoria O. Soldatenkova and Leonid M. Bardenstein and Irina A. Kozlova and Nikolay G. Neznanov and Olga I. Maslova and Andrey S. Petrukhin and Nina K. Sukchotina and Valeriy P. Zykov}, journal={European Child & Adolescent Psychiatry}, year={2009}, volume={19}, pages={57-66} }