PDF(Pubmed)
Abstract：
UNASSIGNED: To compare PRC-063 (multilayer-release methylphenidate) and lisdexamfetamine dimesylate (LDX) on the driving performance of young adults with attention deficit hyperactivity disorder (ADHD) in a randomized, double-blind, crossover study.
UNASSIGNED: Following up to 21 days of each treatment in each treatment course (PRC-063/LDX or LDX/PRC-063), subjects completed a 15-hour driving simulator laboratory assessment. The primary outcome measure was the Tactical Driving Quotient (TDQ) and the Clinical Global Impressions-Improvement (CGI-I) scale was a secondary outcome measure.
UNASSIGNED: Forty-four subjects completed the study. PRC-063 and LDX had equivalent effects on driving performance through a 15-hour time period (least square mean difference -0.3 [standard error 1.08], 95% confidence interval [-2.4, 1.8], p = .793). Consistent improvement in CGI-I was observed. The incidence of treatment-emergent adverse events was similar for each treatment sequence.
UNASSIGNED: PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured.
UNASSIGNED: Following up to 21 days of each treatment in each treatment course (PRC-063/LDX or LDX/PRC-063), subjects completed a 15-hour driving simulator laboratory assessment. The primary outcome measure was the Tactical Driving Quotient (TDQ) and the Clinical Global Impressions-Improvement (CGI-I) scale was a secondary outcome measure.
UNASSIGNED: Forty-four subjects completed the study. PRC-063 and LDX had equivalent effects on driving performance through a 15-hour time period (least square mean difference -0.3 [standard error 1.08], 95% confidence interval [-2.4, 1.8], p = .793). Consistent improvement in CGI-I was observed. The incidence of treatment-emergent adverse events was similar for each treatment sequence.
UNASSIGNED: PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured.
摘要：
■比较PRC-063（多层释放哌醋甲酯）和二甲磺酸盐（LDX）对患有注意力缺陷多动障碍（ADHD）的年轻人的驾驶表现，双盲,交叉研究。
■在每个疗程（PRC-063/LDX或LDX/PRC-063）中每次治疗最多21天，受试者完成了15小时驾驶模拟器实验室评估。主要结果指标是战术驱动商（TDQ），而临床整体印象改善（CGI-I）量表是次要结果指标。
■44名受试者完成了这项研究。PRC-063和LDX在15小时的时间段内对驾驶性能具有等效影响（最小二乘平均差-0.3[标准误差1.08]，95%置信区间[-2.4，1.8]，p=.793）。观察到CGI-I的一致改善。每个治疗序列的治疗引起的不良事件的发生率相似。
■PRC-063和LDX对驾驶性能具有可比的影响，从1到15小时，最后测量的时间点。
■在每个疗程（PRC-063/LDX或LDX/PRC-063）中每次治疗最多21天，受试者完成了15小时驾驶模拟器实验室评估。主要结果指标是战术驱动商（TDQ），而临床整体印象改善（CGI-I）量表是次要结果指标。
■44名受试者完成了这项研究。PRC-063和LDX在15小时的时间段内对驾驶性能具有等效影响（最小二乘平均差-0.3[标准误差1.08]，95%置信区间[-2.4，1.8]，p=.793）。观察到CGI-I的一致改善。每个治疗序列的治疗引起的不良事件的发生率相似。
■PRC-063和LDX对驾驶性能具有可比的影响，从1到15小时，最后测量的时间点。
