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.

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

Déclaration de conflit d'intérêts

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Vishal Madaan: In his current role, Dr. Madaan is an employee with the American Psychiatric Association and has no current disclosures to make. In his prior role as a University of Virginia Health System employee, he received research support from Supernus, Allergan, Boehringer Ingelheim, Pfizer, Purdue, and the NICHD at the time the original manuscript was prepared. Daniel Cox: Dr Cox has received research support as a University of Virginia Health System employee from the National Institutes of Health, Eli Lilly, Purdue, Johnson & Johnson, Dexcom, and Abbott. Graeme Donnelly is an employee of Purdue Pharma (Canada). Sailaja Bhaskar: Sailaja Bhaskar is currently employed at Imbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P.