A Randomized, Phase 3, Double-Blind, Crossover Comparison of Multilayer, Extended-Release Methylphenidate (PRC-063), and Lisdexamfetamine in the Driving Performance of Young Adults With ADHD.

IF 2.7 3区医学 Q2 PSYCHIATRY

Journal of Attention Disorders Pub Date : 2024-04-01 Epub Date: 2024-02-25 DOI:10.1177/10870547241226634

Vishal Madaan, Sailaja Bhaskar, Graeme A E Donnelly, Daniel J Cox

{"title":"A Randomized, Phase 3, Double-Blind, Crossover Comparison of Multilayer, Extended-Release Methylphenidate (PRC-063), and Lisdexamfetamine in the Driving Performance of Young Adults With ADHD.","authors":"Vishal Madaan, Sailaja Bhaskar, Graeme A E Donnelly, Daniel J Cox","doi":"10.1177/10870547241226634","DOIUrl":null,"url":null,"abstract":"Objective: 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.Method: 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.Results: 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.Conclusions: PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured.","PeriodicalId":15237,"journal":{"name":"Journal of Attention Disorders","volume":" ","pages":"947-956"},"PeriodicalIF":2.7000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10981171/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Attention Disorders","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/10870547241226634","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/25 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PSYCHIATRY","Score":null,"Total":0}

引用次数: 0

Abstract

Objective: 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.

Method: 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.

Results: 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.

Conclusions: PRC-063 and LDX had comparable effects on driving performance, from 1 through 15 hours, the last time point measured.

查看原文本刊更多论文

多层、缓释哌醋甲酯（PRC-063）和利司康非他明在多动症年轻成人驾驶表现中的随机、3 期、双盲、交叉比较。

目的在一项随机、双盲、交叉研究中，比较PRC-063（多层释放哌醋甲酯）和二美沙拉秦（LDX）对注意力缺陷多动障碍（ADHD）青壮年驾驶表现的影响：每个疗程（PRC-063/LDX或LDX/PRC-063）中的每个疗程最长治疗21天后，受试者完成15小时的驾驶模拟器实验室评估。主要结果测量为战术驾驶商数（TDQ），次要结果测量为临床总体印象改善量表（CGI-I）：结果：44名受试者完成了研究。PRC-063和LDX对15小时驾驶表现的影响相当（最小平方均差-0.3 [标准误差1.08]，95%置信区间[-2.4, 1.8]，P = .793）。观察到 CGI-I 持续改善。每个治疗序列的治疗突发不良事件发生率相似：结论：PRC-063和LDX对驾驶性能的影响从1小时到15小时（最后测量的时间点）相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of Attention Disorders PSYCHIATRY-

CiteScore

7.60

自引率

6.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Journal of Attention Disorders (JAD) focuses on basic and applied science concerning attention and related functions in children, adolescents, and adults. JAD publishes articles on diagnosis, comorbidity, neuropsychological functioning, psychopharmacology, and psychosocial issues. The journal also addresses practice, policy, and theory, as well as review articles, commentaries, in-depth analyses, empirical research articles, and case presentations or program evaluations.