title: The Time Course of Effect of Multilayer-Release Methylphenidate Hydrochloride Capsules: A Randomized, Double-Blind Study of Adults With ADHD in a Simulated Adult Workplace Environment.
abstract: Objective:The aim of this study is to assess the onset and duration of efficacy of multilayer-release methylphenidate (PRC-063) over 16 hr compared with placebo in adults with ADHD using the simulated adult workplace environment.Method:After dose-optimization with PRC-063, participants entered a double-blind, placebo-controlled, crossover phase. Primary outcome measure was the Permanent Product Measure of Performance (PERMP) total score measured pre-dose and from 1 to 16 hr post-dose.Results:Of the 59 randomized participants, 45 participants completed the study. While receiving PRC-063, adults had greater mean PERMP total scores across all time points compared with placebo (268.7 ± 11.24 vs. 255.6 ± 10.87;p= .0064). Common adverse events were decreased appetite, headache, and insomnia. There was no significant impact on overall sleep quality (p= .9542).Conclusion:PRC-063 significantly improved PERMP scores with an onset within 1 hr post-dose, and maintained improvement throughout the 16 hr post-dose study period compared with placebo in adults with ADHD.
authors.affiliation: AVIDA, Newport Beach, CA, USA.
authors.forename: Sharon B
authors.initials: SB
authors.lastname: Wigal
authors.affiliation: AVIDA, Newport Beach, CA, USA.
authors.forename: Tim
authors.initials: T
authors.lastname: Wigal
authors.affiliation: Center for Psychiatry and Behavioral Medicine Inc., Las Vegas, NV, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: Childress
authors.affiliation: Purdue Pharma Canada, Pickering, Ontario, Canada.
authors.forename: Graeme A E
authors.initials: GAE
authors.lastname: Donnelly
authors.affiliation: Purdue Pharma Canada, Pickering, Ontario, Canada.
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Reiz
mesh_terms: D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D002214:Capsules / Q000627:therapeutic use; D000697:Central Nervous System Stimulants / Q000627:therapeutic use; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D008774:Methylphenidate / Q000627:therapeutic use; D016896:Treatment Outcome; D017132:Workplace
chemical_list: D002214:Capsules; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate
keywords: ADHD; adult workplace environment; methylphenidate