R/D Clinical Research Inc., 461 This Way, Lake Jackson, TX 77566, USA.
J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):171-9. doi: 10.1016/j.jaac.2010.11.005.
This study examined the efficacy and safety of clonidine hydrochloride extended-release tablets (CLON-XR) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).
This 8-week, placebo-controlled, fixed-dose trial, including 3 weeks of dose escalation, of patients 6 to 17 years old with ADHD evaluated the efficacy and safety of CLON-XR 0.2 mg/day or CLON-XR 0.4 mg/day versus placebo in three separate treatment arms. Primary endpoint was mean change in ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline to week 5 versus placebo using a last observation carried forward method. Secondary endpoints were improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating Scale-Revised: Long Form, Clinical Global Impression of Severity, Clinical Global Impression of Improvement, and Parent Global Assessment from baseline to week 5.
Patients (N = 236) were randomized to receive placebo (n = 78), CLON-XR 0.2 mg/day (n = 78), or CLON-XR 0.4 mg/day (n = 80). Improvement from baseline in ADHD-RS-IV total score was significantly greater in both CLON-XR groups versus placebo at week 5. A significant improvement in ADHD-RS-IV total score occurred between groups as soon as week 2 and was maintained throughout the treatment period. In addition, improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating Scale-Revised: Long Form, Clinical Global Impression of Improvement, Clinical Global Impression of Severity, and Parent Global Assessment, occurred in both treatment groups versus placebo. The most common treatment-emergent adverse event was mild-to-moderate somnolence. Changes on electrocardiogram were minor and reflected the known pharmacology of clonidine.
Clonidine hydrochloride extended-release tablets were generally well tolerated by patients in the study and significantly improved ADHD symptoms in this pediatric population.
本研究旨在评估盐酸可乐定控释片（CLON-XR）治疗儿童和青少年注意缺陷多动障碍（ADHD）的疗效和安全性。
这是一项为期 8 周、安慰剂对照、固定剂量的临床试验，纳入年龄为 6 至 17 岁的 ADHD 患者，包括 3 周的剂量递增期，评估 CLON-XR 0.2mg/天或 CLON-XR 0.4mg/天与安慰剂在三个独立治疗组中的疗效和安全性。主要终点是使用末次观测值结转法（LOCF）比较基线至第 5 周时 ADHD 评定量表-IV（ADHD-RS-IV）总分相对于安慰剂的变化。次要终点是 ADHD-RS-IV 注意力不集中和多动/冲动分量表、Conners 父母评定量表修订版：长表、临床总体印象严重程度、临床总体印象改善和父母总体评估自基线至第 5 周的改善。
共 236 名患者被随机分配至安慰剂组（n=78）、CLON-XR 0.2mg/天组（n=78）或 CLON-XR 0.4mg/天组（n=80）。与安慰剂相比，CLON-XR 组在第 5 周时 ADHD-RS-IV 总分的改善均有显著统计学意义。两组间 ADHD-RS-IV 总分的改善在第 2 周即出现显著差异，并在整个治疗期间得以维持。此外，在注意力不集中和多动/冲动分量表、Conners 父母评定量表修订版：长表、临床总体印象改善、临床总体印象严重程度和父母总体评估方面，与安慰剂相比，治疗组也均有显著改善。最常见的治疗相关不良事件是轻至中度嗜睡。心电图的改变较小，反映了可乐定的已知药理学特征。
盐酸可乐定控释片在研究人群中总体耐受性良好，显著改善了该儿科人群的 ADHD 症状。
