PMID- 33017854 OWN - NLM STAT- MEDLINE DCOM- 20210813 LR - 20210813 IS - 1439-0795 (Electronic) IS - 0176-3679 (Linking) VI - 53 IP - 6 DP - 2020 Nov TI - Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients - Results of the COMPAS Study. PG - 263-271 LID - 10.1055/a-1207-9851 [doi] AB - INTRODUCTION: The Comparison of Methylphenidate and Psychotherapy in adult ADHD Study (COMPAS) was a prospective, randomized multicenter clinical trial, comparing methylphenidate (MPH) with placebo (PLAC) in combination with cognitive behavioral group psychotherapy (GPT) or individual clinical management (CM) over the period of 1 year. Here, we report results on treatment safety. METHODS: MPH and PLAC were flexibly dosed. Among 433 randomized patients, adverse events (AEs) were documented and analyzed on an "as received" basis during week 0-52. Electrocardiogram data were recorded at baseline and week 24. RESULTS: Comparing 205 patients who received >/=1 dose of MPH with 209 patients who received PLAC, AEs occurring significantly more frequently in the MPH group were decreased appetite (22 vs. 3.8%), dry mouth (15 vs. 4.8%), palpitations (13 vs. 3.3%), gastrointestinal infection (11 vs. 4.8%), agitation (11 vs. 3.3%), restlessness (10 vs. 2.9%), hyperhidrosis, tachycardia, weight decrease (all 6.3 vs. 1.9%), depressive symptom, influenza (both 4.9 vs. 1.0%), and acute tonsillitis (4.4 vs. 0.5%). Syncope occurred significantly more often in the PLAC group (2.4 vs. 0%). Clinically relevant ECG changes occurred very rarely in both groups. Serious AEs were rare and without a significant group difference. The comparison of 206 patients treated with GPT versus 209 patients who received CM revealed no major differences. Serious AE classified as psychiatric occurred in 5 cases in the CM group and in 1 case in the GPT group. CONCLUSION: In this so far longest-running clinical trial, methylphenidate treatment was safe and well-tolerated. CI - Thieme. All rights reserved. FAU - Kis, Bernhard AU - Kis B AD - Department of Psychiatry, Psychotherapy and Psychosomatics, St. Elisabeth Hospital Niederwenigern, Contilia Group, Hattingen, Germany. AD - Department of Psychiatry and Psychotherapy, University Medical Center, Gottingen, Germany. AD - LVR-Hospital Essen, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany. FAU - Lucke, Caroline AU - Lucke C AD - Department of Psychiatry and Psychotherapy - University of Bonn, Bonn, Germany. FAU - Abdel-Hamid, Mona AU - Abdel-Hamid M AD - Department of Psychiatry and Psychotherapy, University Medical Center, Gottingen, Germany. AD - LVR-Hospital Essen, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany. FAU - Hessmann, Philipp AU - Hessmann P AD - Department of Psychiatry and Psychotherapy, University Medical Center, Gottingen, Germany. FAU - Graf, Erika AU - Graf E AD - Institute of Medical Biometry and Statistics, Clinical Trials Unit and Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany. FAU - Berger, Mathias AU - Berger M AD - Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany. FAU - Matthies, Swantje AU - Matthies S AD - Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany. FAU - Borel, Patricia AU - Borel P AD - Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany. FAU - Sobanski, Esther AU - Sobanski E AD - Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany. AD - Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany. FAU - Alm, Barbara AU - Alm B AD - Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany. FAU - Rosler, Michael AU - Rosler M AD - Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany. FAU - Retz, Wolfgang AU - Retz W AD - Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany. AD - Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany. FAU - Jacob, Christian AU - Jacob C AD - Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany. FAU - Colla, Michael AU - Colla M AD - Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland. FAU - Huss, Michael AU - Huss M AD - Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany. FAU - Jans, Thomas AU - Jans T AD - University Hospital of Wurzburg, Center of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Wurzburg, Germany. FAU - van Elst, Ludger Tebartz AU - van Elst LT AD - Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany. FAU - Muller, Helge H O AU - Muller HHO AD - Witten/Herdecke University, Faculty of Health/School of Medicine, Integrative Psychiatry and Psychotherapy, Witten, Germany. FAU - Philipsen, Alexandra AU - Philipsen A AD - Department of Psychiatry and Psychotherapy - University of Bonn, Bonn, Germany. LA - eng GR - German Federal Ministry of Research and Education/01GV0606/ PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20201005 PL - Germany TA - Pharmacopsychiatry JT - Pharmacopsychiatry JID - 8402938 RN - 0 (Central Nervous System Stimulants) RN - 207ZZ9QZ49 (Methylphenidate) SB - IM MH - Adolescent MH - Adult MH - Attention Deficit Disorder with Hyperactivity/*drug therapy MH - Central Nervous System Stimulants/*adverse effects/therapeutic use MH - Cognitive Behavioral Therapy/methods MH - Combined Modality Therapy MH - Double-Blind Method MH - Drug-Related Side Effects and Adverse Reactions/epidemiology MH - Female MH - Humans MH - Male MH - Methylphenidate/*adverse effects/therapeutic use MH - Middle Aged MH - Patient Safety MH - Prospective Studies MH - Young Adult COIS- Bernhard Kis has served on the advisory board of Medice, Shire and Servier and has received speaking honoraria by MEDICE Arzneimittel Putter GmbH and Co KG within the last three years. Erika Graf received personal fees from Roche Pharma AG, outside the submitted work. Mathias Berger is a member of the advisory board of the Oberberg Hospital Group and textbook author published by Elsevier. Swantje Matthies has been involved in clinical trials conducted by Janssen and Lundbeck as a study physician. Esther Sobanski has served on advisory boards of MEDICE Arzneimittel Putter GmbH and Co. KG, Eli Lilly and Co and Shire. Michael Rosler has during the last 3 years been part of advisory boards and speaker for Medice Arzneimittel, Novartis, Shire and Lilly. He has performed phase 3 studies for Medice. Wolfgang Retz has served on the advisory board of MEDICE and has been involved in treatment studies performed by NOVARTIS and MEDICE. He has received royalties for publications concerning diagnostic tools and psychosocial treatment of ADHD from Elsevier, Hogrefe and Kohlhammer publishers. Christian Jacob has received speakers' honoraria from Shire and Jansen and is a member of the Advisory Board of the Medical Education Steering Committee of the latter company. Michael Colla has served on advisory boards, received speaker's honoraria, or performed phase 3 studies with Shire, Eli Lilly and Co, and Novartis. Michael Huss has received personal fees, non-financial support or grants within the last 3 years by Shire, MEDICE Arzneimittel Putter GmbH and Co. KG, Novartis, Eli Lilly, Engelhard Arzneimittel and Actelion. He holds the patents DE 10221839 B4 and US 20050131292 A1 on doppler radar. Ludger Tebartz van Elst has given talks and workshops on different medical issues including ADHD indirectly payed for by different institutions and pharmaceutical companies. He has received funding for research projects into neurodevelopmental disorders including ADHD from the DFG and BMBF and has published several books and book chapters. Alexandra Philipsen has served on advisory boards, given lectures, performed phase 3 studies, or received travel grants within the last 3 years from Eli Lilly and Co, Janssen-Cilag, MEDICE Arzneimittel Putter GmbH and Co KG, Novartis, and Shire; and has authored books and articles on psychotherapy published by Elsevier, Hogrefe, Schattauer, Kohlhammer, Karger, Springer, and Oxford Press. All other authors declare that they have no competing interests. EDAT- 2020/10/06 06:00 MHDA- 2021/08/14 06:00 CRDT- 2020/10/05 20:11 PHST- 2020/10/06 06:00 [pubmed] PHST- 2021/08/14 06:00 [medline] PHST- 2020/10/05 20:11 [entrez] AID - 10.1055/a-1207-9851 [doi] PST - ppublish SO - Pharmacopsychiatry. 2020 Nov;53(6):263-271. doi: 10.1055/a-1207-9851. Epub 2020 Oct 5.