Efficacy and safety of prolonged-release OROS methylphenidate in adults with attention deficit/hyperactivity disorder: A 13-week, randomized, double-blind, placebo-controlled, fixed-dose study

Abstract

Objectives. Methylphenidate (MPH) is effective for adults with attention-deficit/hyperactivity disorder (ADHD). This study aimed to evaluate the efficacy and safety of OROS MPH in adults with ADHD. Methods. Randomized, double-blind study; 279 subjects received OROS MPH 54 or 72 mg/day, or placebo, for 13 weeks. Primary endpoint was the Conners’ Adult ADHD Rating Scale – Screening Version (CAARS-O:SV). Secondary outcomes included CAARS Self Report – Short Version (CAARS-S:S), Sheehan Disability Scale (SDS) and ADHD Impact Module – Adult (AIM-A). Results. Improvements in CAARS-O:SV were significantly greater with OROS MPH 72 mg vs. placebo (P = 0.0024). CAARS-S:S scores decreased significantly vs. placebo in both OROS MPH arms (P < 0.05). There was no significant change in SDS score from baseline in either treatment arm, although significant benefit vs. placebo was observed on several AIM-A subscales. Treatment was well tolerated. Conclusions. OROS MPH provided overall benefits in the treatment of adults with ADHD.

Key words::

• Adults
• attention deficit hyperactivity disorder
• OROS methylphenidate
• randomized controlled trial
• treatment efficacy

Acknowledgements

The study was funded by Janssen-Cilag EMEA. The authors thank Pat Calaiaro (Johnson & Johnson Pharmaceutical Research & Development, LLC) for help with project management, Elke van Riijk and Paul Ysebaert (SGS Life Science Services, Mechelen, Belgium) for trial management, and Margaret Rothman and Kai Fai Ho (Johnson & Johnson Pharmaceutical Services, LLC) for providing the mediator analyses. The authors would also like to thank the study subjects for their participation in the trial. Editorial assistance with the drafting and completion of the manuscript was provided by Daniel Booth (Bioscript Stirling, London, UK) and funded by Janssen–Cilag EMEA.

Study investigators: Steven Stes, Frieda Matthys, Andy De Witte, Laurent Victoor, Pierre Oswald, Mogens Brødsgaard, Hans Henrik Wernlund, Ole Nielsen, Asko Niemelä, Marko Sorvaniemi, Martti Heikkinen, Sami Leppämäki, Franck Baylé, Hervé Caci, Yves Dauvilliers, Eric Konofal, Andreas Heinz, Bernhard Kis, Martin Klein, Götz-Erik Trott, Lothar Imhof, Esther Sobanski, Thomas Nissen, Alexandra Philipsen, Michael Riedel, Georg Winterer, Torbjorn Tvedten, Kirsti Hansen, Odd Augland, Lege Espen Anker, Miguel Casas, Javier Cotobal, José Luis Carrasco, Ylva Ginsberg, Patrick Westin, Baba Pendse, Peter Bosson, Dan Edvinsson, Per Woxler, Maria Hofecker, Dominique Eich, Jan Buitelaar, Sandra Kooij, Marios Adamou, Anthony Hale, Johannes Thome, Ulrich Muller.

Statement of Interest

M. Casas has, in the past 3 years, been a consultant, a member of an advisory board and/or a speaker for Janssen–Cilag, Eli Lilly, Shire and Rubió. He has received research grants from Janssen–Cilag, Rubió and Eli Lilly. M. Rösler is a consultant for Janssen–Cilag, Medice, Lilly and Shire, and is a member of the speaker's bureau of Janssen–Cilag, Medice and Shire. J.J.S. Kooij has been a speaker for Janssen–Cilag BV and Eli Lilly and has received research grants from Janssen–Cilag BV and Shire. Y. Ginsberg has served as a consultant and speaker for Janssen–Cilag and Novartis and as a speaker for Lundbeck. She is a principal investigator for the LAMDA-I and LAMDA-II studies, funded by Janssen–Cilag. J.A. Ramos-Quiroga has, in the past 3 years, been a consultant, a member of an advisory board and/or a speaker for Janssen–Cilag, Eli Lilly, Shire and Rubió. He has received research grants from Janssen–Cilag, Rubió, Eli Lilly and Alicia Koplowitz Foundation. S. Heger is a former employee of Janssen–Cilag EMEA, and has since acted as a speaker and consultant for the company. J. Berwaerts is an employee of Johnson & Johnson Pharmaceutical Research & Development. J. Dejonkheere is a consultant working on behalf of SGS–Life Science Services, a company employed by Janssen–Cilag EMEA to provide statistical analysis. B. Schäuble and E. van der Vorst are employees of Janssen–Cilag EMEA.