Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study Grazia Dell'Agnello a , Dino Maschietto b , Carmela Bravaccio c , Filippo Calamoneri d , Gabriele Masi e , Paolo Curatolo f , Dante Besana g , Francesca Mancini a , Andrea Rossi a , Lynne Poole h , Rodrigo Escobar i , Alessandro Zuddas j, ⁎ for the LYCY Study Group a Medical Department, Eli Lilly Italia, Italy b Operative Unit of Child Neuropsychiatry, Azienda USL n 10 Veneto Orientale, San Donà di Piave, Venezia, Italy c Department of Pediatrics, University of Naples "Federico II", Italy d Clinic of Child Neuropsychiatry, University Policlinic of Messina, Italy e Department of Child Neuropsychiatry, IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italy f Department of Child Neuropsychiatry, Tor Vergata University of Rome, Italy g Operative Structure of Child Neuropsychiatry, Hospital of Alessandria, Italy h Eli Lilly and Co. UK i European Medical Department, Eli Lilly and Co. Alcobendas, Madrid, Spain j Department of Neuroscience, Section of Child Neuropsychiatry, University of Cagliari, Italy Received 3 January 2009; received in revised form 2 July 2009; accepted 23 July 2009 KEYWORDS Atomoxetine; Attention-deficit/ hyperactivity disorder; Oppositional defiant disorder Abstract Objective: The primary aim of this study was to assess the efficacy of atomoxetine in improving ADHD and ODD symptoms in paediatric patients with ADHD and comorbid oppositional defiant disorder (ODD), non-responders to previous psychological intervention with parent support. Methods: This was a multicentre, randomised, placebo-controlled trial conducted in patients aged 6–15 years, with ADHD and ODD diagnosed according to the DSM-IV criteria by a structured ⁎ Corresponding author. Centre for Pharmacological Therapies in Child and Adolescent Neuropsychiatry, Department of Neuroscience, University of Cagliari, via Ospedale, 46, 09124 Cagliari, Italy. Tel.: +39 070 609 3509/3510; fax: +39 070 669591. E-mail address: azuddas@unica.it (A. Zuddas). 0924-977X/$ - see front matter © 2009 Elsevier B.V. and ECNP. All rights reserved. doi:10.1016/j.euroneuro.2009.07.008 www.elsevier.com/locate/euroneuro European Neuropsychopharmacology (2009) 19, 822–834