Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study
Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study
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DOI：
10.1016/j.euroneuro.2009.07.008
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发表时间：
2009-11-01
影响因子：
5.6
通讯作者：
Zuddas, Alessandro
中科院分区：
文献类型：
--
作者：
Dell'Agnello, Grazia;Maschietto, Dino;Zuddas, Alessandro
目标：本研究的主要目的是评估托莫西汀在改善患有ADHD和共病对立违抗性障碍（ODD）的儿科患者（在父母支持下对既往心理干预无反应者）的ADHD和ODD症状方面的疗效。研究方法：这是一项在6-15岁的ADHD和ODD患者中进行的多中心、随机、安慰剂对照试验，通过结构化临床访谈（K-SADS-PL）根据DSM-IV标准诊断。在随后的8周双盲期，仅6周标准化父母培训无应答的受试者被随机分配至托莫西汀组（高达1.2 mg/kg/天）或安慰剂组（比例为3：1）。结果如下：入组父母支持阶段的156例患者中，只有2例（92.9%的伴侣;平均年龄：9.9岁）在父母培训计划后改善; 139例患者随机进入研究，137例有资格进行疗效分析。在随机双盲期结束时，托莫西汀组和安慰剂组的Swanson、Nolan和Pelham评定量表修订版（SNAP-IV）ADHD子量表的平均变化分别为-8.1 +/- 9.2和-2.0 +/- 4.7（p
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 clinical interview (K-SADS-PL). Only subjects who are non-responders to a 6-week standardized parent training were randomised to atomoxetine (up to 1.2 mg/kg/day) or placebo (in a 3:1 ratio) for the following 8-week double blind phase. Results: Only 2 of the 156 patients enrolled for the parent support phase (92.9% of mates; mean age: 9.9 years), improved after the parent training program; 139 patients were randomised for entering in the study and 137 were eligible for efficacy analysis. At the end of the randomised double blind phase, the mean changes in the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV) ADHD subscale were -8.1 +/- 9.2 and -2.0 +/- 4.7, respectively in the atomoxetine and in the placebo group (p