Article Information
Corresponding Author: Alexandra Philipsen, MD, Medical Campus University of Oldenburg, School of Medicine and Health Sciences, Psychiatry and Psychotherapy–University Hospital, Karl-Jaspers-Klinik, D-26111 Oldenburg, Germany ([email protected]).
Submitted for Publication: April 17, 2015; final revision received August 17, 2015; accepted August 18, 2015.
Published Online: November 4, 2015. doi:10.1001/jamapsychiatry.2015.2146.
Author Contributions: Drs Philipsen and Graf had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Berger and Tebartz van Elst contributed equally.
Study concept and design: Philipsen, Jans, Graf, Alm, Retz, Ihorst, Schlander, Berger, Tebartz van Elst.
Acquisition, analysis, or interpretation of data: Philipsen, Jans, Graf, Matthies, Borel, Colla, Gentschow, Langner, Jacob, Groß-Lesch, Sobanski, Schumacher-Stien, Roesler, Retz, Retz-Junginger, Kis, Abdel-Hamid, Heinrich, Huss, Kornmann, Bürger, Perlov, Schlander, Berger, Tebartz van Elst.
Drafting of the manuscript: Philipsen, Graf, Colla, Retz, Heinrich, Tebartz van Elst.
Critical revision of the manuscript for important intellectual content: Philipsen, Jans, Graf, Matthies, Borel, Colla, Gentschow, Langner, Jacob, Groß-Lesch, Sobanski, Alm, Schumacher-Stien, Roesler, Retz-Junginger, Kis, Abdel-Hamid, Huss, Kornmann, Bürger, Perlov, Ihorst, Schlander, Berger, Tebartz van Elst.
Statistical analysis: Philipsen, Graf, Tebartz van Elst.
Obtained funding: Philipsen, Jans, Tebartz van Elst.
Administrative, technical, or material support: Philipsen, Jans, Matthies, Borel, Colla, Gentschow, Langner, Jacob, Groß-Lesch, Schumacher-Stien, Roesler, Retz-Junginger, Kis, Abdel-Hamid, Huss, Kornmann, Perlov, Schlander, Berger, Tebartz van Elst.
Study supervision: Philipsen, Colla, Gentschow, Langner, Sobanski, Roesler, Retz, Retz-Junginger, Kis, Huss, Tebartz van Elst.
Conflict of Interest Disclosures: Dr Philipsen reported serving on advisory boards, giving lectures, performing phase 3 studies, or receiving travel grants within the last 3 years from Eli Lilly and Co, Janssen-Cilag, MEDICE Arzneimittel Pütter GmbH and Co KG, Novartis, and Shire; and has authored books and articles on psychotherapy published by Elsevier, Hogrefe, Schattauer, Kohlhammer, and Karger. Dr Matthies reported receiving a speaker’s fee from Janssen-Cilag; and involvement in clinical trials conducted by Janssen-Cilag and Eli Lilly and Co. Dr Colla reported serving on advisory boards, receiving speaker’s honoraria, or performing phase 3 studies within the last 3 years with Shire, Eli Lilly and Co, and Novartis. Dr Jacob reported receiving speaker’s honoraria from MEDICE; serving as an advisory board member of Eli Lilly and Co; performing phase 3 studies at MEDICE, Novartis, Janssen-Cilag, Eli Lilly and Co; and performing an investigator-initiated trial with Eli Lilly and Co. Dr Sobanski reported receiving speaker’s honoraria from MEDICE, Eli Lilly and Co, and Novartis; serving as an advisory board member of MEDICE, Shire, and Eli Lilly and Co; and performing phase 3 studies and investigator-initiated trials with MEDICE, Novartis, Janssen-Cilag, and Eli Lilly and Co. Dr Alm reported receiving speaker’s honoraria from MEDICE; serving on the advisory board of Eli Lilly and Co; performing phase 3 studies at MEDICE, Novartis, Janssen-Cilag, Eli Lilly and Co; and performing an investigator-initiated trial with Eli Lilly and Co. Dr Roesler reported serving as an advisory board member of MEDICE, Eli Lilly and Co, and Janssen-Cilag; serving as a member of the speakers bureau of MEDICE, Eli Lilly and Co, Shire, and Novartis; and performing clinical studies for MEDICE. Dr Retz reported receiving speaker’s honoraria from and serving as an advisory board member of MEDICE, Shire, and Novartis; and performing clinical trials for BMBF, Novartis, Vifor, and MEDICE. Dr Kis reported receiving speaker’s honoraria from MEDICE, Servier, and Eli Lilly and Co; and serving as an advisory board member of MEDICE, Novartis, and Servier. Dr Huss reported serving as an advisory board member of Eli Lilly and Co, Engelhardt Arzneimittel, Janssen-Cilag, MEDICE, Novartis, Shire, and Steiner Arzneimittel within the past 5 years; serving as consultant to Engelhardt Arzneimittel, MEDICE, and Steiner Arzneimittel; receiving honoraria from Eli Lilly and Co, Engelhard Arzneimittel, Janssen-Cilag, MEDICE, Novartis, and Shire; and receiving unrestricted grants for investigator-initiated trials from Eli Lilly and Co, MEDICE, Engelhard Arzneimittel, and Steiner Arzneimittel. Mr Schlander reported receiving research support from sick funds, physicians’ associations, health technology agencies, industry associations, and biopharmaceutical enterprises, including Janssen (Johnson & Johnson) and Shire, all under unrestricted educational grant policy. Dr Tebartz van Elst reported serving on advisory boards, giving lectures, or receiving travel grants within the last 3 years from Eli Lilly and Co, Janssen-Cilag, Novartis, Shire, UCB, GlaxoSmithKline, Servier, Janssen-Cilag, and Cyberonics. No other disclosures were reported.
Funding/Support: This study was part of a multicenter research network on the psychotherapy of ADHD, funded by grants 01GV0605 and 01GV0606 from the German Federal Ministry of Education and Research. MEDICE Arzneimittel Puetter GmbH and Co KG provided the trial medication (Medikinet retard licensed as Medikinet adult and matching placebo).
Role of the Funder/Sponsor: The German Federal Ministry of Education and Research and MEDICE Arzneimittel Puetter GmbH and Co KG had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS) Consortium includes the following members: Michael Colla, MD, Laura Gentschow, Paula Kunze, and Daina Langner, PhD, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité–University Medicine Berlin, Berlin, Germany; Bernhard Kis, MD, Mona Abdel-Hamid, PhD, Viola Heinrich, Markus Krämer, MD, and Jennifer Uekermann, PhD, Department of Psychiatry and Psychotherapy, LVR-Hospital Essen, Faculty of Medicine, University of Duisburg-Essen, Duisburg and Essen, Germany; Alexandra Philipsen, MD (coordinating investigator), Erika Graf, PhD, Swantje Matthies, MD, Marc Loewer, MD, Patricia Borel, Imke Jansen, Steffi Bonfico, Manuel Jooßens, Chiharu Sadohara, Manfred Weber, Melanie Kamp, Tatja Dopatka, Evgeniy Perlov, MD, and Harald Richter, PhD, Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany; Michael Roesler, MD, Wolfgang Retz, MD, Petra Retz-Junginger, PhD, Konstanze Roemer, Birgit Leipnitz, MD, Sabine Doyran, MD, and Monika Schulte-Altedorneburg, MD, Institute for Forensic Psychology and Psychiatry, Saarland University Medical Center and Saarland University Faculty of Medicine, Homburg/Saar, Germany; Christine Carl, PhD, and Clemens Keutler, MD, Department of Child and Adolescent Psychiatry and Psychotherapy, St Elisabethen Krankenhaus, Lörrach, Germany; Michael Huss, MD, Catherine Kornmann, Arne Bürger, Galina Chervenkova, and Patricia Meinhardt, Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany; Esther Sobanski, MD, Barbara Alm, MD, Martina Schumacher-Stien, Simon Bukow, MD, and Sotiria Argiriou-Martin, Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany; Christian Jacob, MD, Thomas Jans, PhD, Silke Groß-Lesch, MD, Monika Heine, MD, Andrea Boreatti-Hümmer, MD, Julia Heupel, Susanne Reichert, Sabine Müller, Susanne Kreiker, Alexandra Gessner, Annette Conzelmann, and Christina Bähne, Department of Psychiatry, Psychosomatics and Psychotherapy and Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; and Rainer Bredenkamp (director), Gabriele Ihorst, PhD, and Erika Graf, PhD, Clinical Trials Unit, University Medical Center, University of Freiburg, Freiburg, Germany. The independent data monitoring committee included Helmut Remschmidt, MD, Department of Child and Adolescent Psychiatry, Philipps University, Marburg, Germany; Gernot Wassmer, PhD, Institute for Medical Statistics, Informatics, and Epidemiology, University of Cologne, Cologne, Germany; and Norbert Wodarz, MD, Department of Psychiatry, University of Regensburg, Regensburg, Germany.
Additional Information: Other projects in our network on psychotherapy research in ADHD (speaker: Dr Philipsen; 2006-2012, Andreas Warnke, MD, University Hospital of Würzburg, Würzburg, Germany) are coordinated by Dr Jans (ADHD in mothers and children), Dr Tebartz van Elst (functional and morphometric brain mapping), and Klaus-Peter Lesch, MD, University Hospital of Würzburg (molecular genetics).
Additional Contributions: We thank Harald Richter, PhD, who was a brilliant and humorous cognitive behavioral therapy and dialectical behavioral therapy teacher and who died unexpectedly in January 2015. James Carpenter, BSc, MSc, DPhil, FHEA, London School of Hygiene and Tropical Medicine, London, England, provided advice on the conception and implementation of the LMCF analyses; he received no compensation. Roland Fischer, MD, MEDICE Arzneimittel Pütter GmbH and Co KG, Iserlohn, Germany, gave advice on preparing the study protocol and assisted in managing serious adverse events; he received no compensation. Independent supervision was carried out by Ulrike Frank, PhD, Institute for Psychology, University of Freiburg, Freiburg, Germany, in cooperation with colleagues Friederike Mayer-Bruns, MD, in private practice, and Kirsten Schehr, Dipl Psych, in private practice. Teaching was carried out by the coordinating investigator, the supervisors, and Dr Richter. Mr Schlander planned and conducted the health economic evaluation.
Correction: This article was corrected to fix an omission in author affiliations on November 12, 2015.
Received April 17, 2015
Final August 17, 2015
Accepted August 18, 2015
