Safety and tolerability of atomoxetine hydrochloride in a long-term, placebo-controlled randomized withdrawal study in European and non-European adults with attention-deficit/hyperactivity disorder

• Published in: The European journal of psychiatry Vol. 27; no. 3; pp. 206 - 224
• Main Authors: Camporeale, Angelo, Upadhyaya, Himanshu, Ramos-Quiroga, J. Antoni, Williams, David, Tanaka, Yoko, Lane, Jeannine R., Escobar, Rodrigo, Trzepacz, Paula, Allen, Albert J
• Format: Journal Article
• Language: English
• Published: Universidad de Zaragoza 01.07.2013
• Subjects: Atomoxetine; Attention deficit hyperactivity disorder; Behavioral Sciences; Critical incidents; Discontinued; Hyperactivity; Neurosciences; Psychiatry; Public, Environmental & Occupational Health; Safety; Adult; Atomoxetine; Attention-deficit/hyperactivity disorder; European
• ISSN: 0213-6163
• DOI: 10.4321/S0213-61632013000300005

Background and Objectives: Safety and tolerability of atomoxetine were studied in the largest double-blind, placebo-controlled, randomised withdrawal trial of atomoxetine (80 or 100 mg/day) in adults with attention-deficit/hyperactivity disorder (ADHD). Methods: Patients (N = 2017), 18 to 50 years of age, with ADHD were enrolled from 18 countries. Patients who responded to atomoxetine during a 12-week open-label treatment phase and maintained that response during a 12-week double-blind maintenance phase were randomised to atomoxetine (N = 266) or placebo (N = 258) for 25 weeks of double-blind treatment. Treatment differences were compared for serious adverse events (AEs), treatment-emergent AEs (TEAEs), discontinuation due to AEs, vital signs, body weight, and electrocardiograms. Adapted from the source document.