Department of Child and Adolescent Psychiatry, Central Institute of Mental Health, Mannheim, Germany.
J Clin Psychopharmacol. 2012 Oct;32(5):653-60. doi: 10.1097/JCP.0b013e318267c304.
The primary objective of this study was to evaluate the efficacy of atomoxetine (ATX) on attention-deficit/hyperactivity disorder (ADHD)-related symptoms assessed as standard variables of a computer-based continuous performance test (cb-CPT) combined with a motion-tracking (MT) device. This was a 2-arm, 8-week, randomized, double-blind, placebo-controlled study in patients with ADHD (6-12 years). Therapy with ATX started with 0.5 mg/kg per day for 1 week, followed by 7 weeks on the target dosage of 1.2 mg/kg per day. Primary outcomes were cb-CPT/MT standard scores after 8 weeks using mixed models for repeated measurements. In addition, investigator-rated ADHD Rating Scale (ADHD-RS), Weekly Ratings of Evening and Morning Behavior (WREMB), and Clinical Global Impression - Severity-ADHD (CGI-S-ADHD) scores were assessed. Of 128 patients randomized, 125 were evaluated (ATX/placebo: 63/62). Baseline characteristics were comparable in both groups (overall, 80.2% boys; mean [SD] age, 9.0 [1.79] years; comorbid Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis, 40.0% oppositional defiant disorder/conduct disorder; prior stimulant treatment, 24.8%; ADHD-RS total score, 36.99 [11.56]). At week 8, all cb-CPT/MT q-scores were significantly reduced versus placebo (all P < 0.001) with effect sizes (ESs) of reaction time (RT) variation (ES = 0.71), mean RT (ES = 0.41), number of microevents (ES = 1.00), commission error rate (ES = 0.50), distance of movement (ES = 0.90), area of movement (ES = 1.08), omission error rate (ES = 0.70), time active (ES = 0.69), motion simplicity (ES = 0.38), and normalized variance of RT (ES = 0.50). Secondary end points also improved significantly in favor of ATX: ADHD-RS (total score ES = 1.30, P < 0.001; hyperactivity/impulsivity subscore ES = 1.37, P < 0.001; inattention subscore ES = 1.07, P < 0.001), WREMB (total score ES = 1.00, P < 0.001; morning subscore ES = 0.59, P = 0.002; evening subscore ES = 1.02, P < 0.001), CGI-S-ADHD (ES = 1.11, P < 0.001). The results of this study show that ATX for 8 weeks significantly reduced ADHD-related symptoms as measured by the cb-CPT/MT.
本研究的主要目的是评估阿托西汀（ATX）对注意力缺陷多动障碍（ADHD）相关症状的疗效，这些症状是通过基于计算机的连续表现测试（cb-CPT）和运动跟踪（MT）设备的标准变量评估的。这是一项为期 8 周、随机、双盲、安慰剂对照的研究，纳入了 6-12 岁的 ADHD 患者。ATX 治疗从 0.5mg/kg/天开始，持续 1 周，然后以 1.2mg/kg/天的目标剂量治疗 7 周。主要结局是使用重复测量混合模型评估 8 周后的 cb-CPT/MT 标准评分。此外，还评估了 ADHD 评定量表（ADHD-RS）、晚间和晨间行为每周评定（WREMB）和临床总体印象-严重程度-ADHD（CGI-S-ADHD）评分。在 128 名随机患者中，有 125 名患者接受了评估（ATX/安慰剂：63/62）。两组的基线特征无显著差异（总体而言，80.2%为男性；平均[SD]年龄为 9.0[1.79]岁；合并诊断与统计手册，第四版诊断，40.0%对立违抗性障碍/品行障碍；既往兴奋剂治疗，24.8%；ADHD-RS 总分，36.99[11.56]）。第 8 周时，与安慰剂相比，所有 cb-CPT/MT q 评分均显著降低（均 P<0.001），反应时（RT）变化的效应量（ES）为 0.71，平均 RT（ES）为 0.41，微事件数量（ES）为 1.00，错误率（ES）为 0.50，运动距离（ES）为 0.90，运动面积（ES）为 1.08，遗漏错误率（ES）为 0.70，活动时间（ES）为 0.69，运动简单性（ES）为 0.38，RT 变异的归一化方差（ES）为 0.50）。次要终点也明显改善，有利于 ATX：ADHD-RS（总分 ES = 1.30，P<0.001；多动/冲动分量表 ES = 1.37，P<0.001；注意力不集中分量表 ES = 1.07，P<0.001），WREMB（总分 ES = 1.00，P<0.001；早晨分量表 ES = 0.59，P=0.002；傍晚分量表 ES = 1.02，P<0.001），CGI-S-ADHD（ES = 1.11，P<0.001）。这项研究的结果表明，ATX 治疗 8 周可显著降低 cb-CPT/MT 测量的 ADHD 相关症状。
