{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T22:14:11Z","timestamp":1787004851916,"version":"build-2736575974"},"reference-count":29,"publisher":"Georg Thieme Verlag KG","issue":"06","funder":[{"name":"German Federal Ministry of Research and\n                        Education","award":["01GV0606"],"award-info":[{"award-number":["01GV0606"]}]},{"name":"German network for the treatment of ADHD in children and adults"},{"name":"MEDICE Arzneimittel Puetter GmbH and Co KG"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacopsychiatry"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Introduction The Comparison of Methylphenidate and Psychotherapy in adult\n                    ADHD Study (COMPAS) was a prospective, randomized multicenter clinical trial,\n                    comparing methylphenidate (MPH) with placebo (PLAC) in combination with\n                    cognitive behavioral group psychotherapy (GPT) or individual clinical management\n                    (CM) over the period of 1 year. Here, we report results on treatment safety.<\/jats:p>\n                  <jats:p>Methods MPH and PLAC were flexibly dosed. Among 433 randomized patients,\n                    adverse events (AEs) were documented and analyzed on an \u201cas\n                    received\u201d basis during week 0\u201352. Electrocardiogram data were\n                    recorded at baseline and week 24.<\/jats:p>\n                  <jats:p>Results Comparing 205 patients who received \u22651 dose of MPH with\n                    209 patients who received PLAC, AEs occurring significantly more frequently in\n                    the MPH group were decreased appetite (22 vs. 3.8%), dry mouth (15 vs.\n                    4.8%), palpitations (13 vs. 3.3%), gastrointestinal infection\n                    (11 vs. 4.8%), agitation (11 vs. 3.3%), restlessness (10 vs.\n                    2.9%), hyperhidrosis, tachycardia, weight decrease (all 6.3 vs.\n                    1.9%), depressive symptom, influenza (both 4.9 vs. 1.0%), and\n                    acute tonsillitis (4.4 vs. 0.5%). Syncope occurred significantly more\n                    often in the PLAC group (2.4 vs. 0%). Clinically relevant ECG changes\n                    occurred very rarely in both groups. Serious AEs were rare and without a\n                    significant group difference. The comparison of 206 patients treated with GPT\n                    versus 209 patients who received CM revealed no major differences. Serious AE\n                    classified as psychiatric occurred in 5 cases in the CM group and in 1 case in\n                    the GPT group.<\/jats:p>\n                  <jats:p>Conclusion In this so far longest-running clinical trial, methylphenidate\n                    treatment was safe and well-tolerated.<\/jats:p>","DOI":"10.1055\/a-1207-9851","type":"journal-article","created":{"date-parts":[[2020,10,5]],"date-time":"2020-10-05T18:58:57Z","timestamp":1601924337000},"page":"263-271","source":"Crossref","is-referenced-by-count":30,"title":["Safety Profile of Methylphenidate Under Long-Term Treatment in Adult\n                    ADHD Patients \u2013 Results of the COMPAS Study"],"prefix":"10.1055","volume":"53","author":[{"given":"Bernhard","family":"Kis","sequence":"first","affiliation":[{"name":"Department of Psychiatry, Psychotherapy and Psychosomatics,\n                    St. Elisabeth Hospital Niederwenigern, Contilia\n                    Group, Hattingen, Germany"},{"name":"Department of Psychiatry and Psychotherapy, University\n                    Medical Center, G\u00f6ttingen, Germany"},{"name":"LVR-Hospital Essen, Department of Psychiatry and\n                    Psychotherapy, Faculty of Medicine, University of\n                    Duisburg-Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"L\u00fccke","sequence":"first","affiliation":[{"name":"Department of Psychiatry and Psychotherapy \u2013 University\n                    of Bonn, Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludger Tebartz","family":"van Elst","sequence":"first","affiliation":[{"name":"Department of Psychiatry and Psychotherapy, Medical\n                    Faculty, University Medical Center \u2013 University of\n                    Freiburg, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helge H. O.","family":"M\u00fcller","sequence":"first","affiliation":[{"name":"Witten\/Herdecke University, Faculty of Health\/School of\n                    Medicine, Integrative Psychiatry and Psychotherapy,\n                    Witten, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Philipsen","sequence":"first","affiliation":[{"name":"Department of Psychiatry and Psychotherapy \u2013 University\n                    of Bonn, Bonn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mona","family":"Abdel-Hamid","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychotherapy, University\n                    Medical Center, G\u00f6ttingen, Germany"},{"name":"LVR-Hospital Essen, Department of Psychiatry and\n                    Psychotherapy, Faculty of Medicine, University of\n                    Duisburg-Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp","family":"He\u00dfmann","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychotherapy, University\n                    Medical Center, G\u00f6ttingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika","family":"Graf","sequence":"additional","affiliation":[{"name":"Institute of Medical Biometry and Statistics, Clinical\n                    Trials Unit and Medical Faculty, University Medical\n                    Center \u2013 University of Freiburg, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathias","family":"Berger","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychotherapy, Medical\n                    Faculty, University Medical Center \u2013 University of\n                    Freiburg, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swantje","family":"Matthies","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychotherapy, Medical\n                    Faculty, University Medical Center \u2013 University of\n                    Freiburg, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Borel","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychotherapy, Medical\n                    Faculty, University Medical Center \u2013 University of\n                    Freiburg, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Sobanski","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychotherapy, Central\n                    Institute of Mental Health, Clinical Faculty Mannheim,\n                    University of Heidelberg, Mannheim, Germany"},{"name":"Department of Child and Adolescent Psychiatry and\n                    Psychotherapy, University Medicine Mainz, Mainz,\n                    Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Alm","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychotherapy, Central\n                    Institute of Mental Health, Clinical Faculty Mannheim,\n                    University of Heidelberg, Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"R\u00f6sler","sequence":"additional","affiliation":[{"name":"Institute for Forensic Psychology and Psychiatry,\n                    Saarland University Faculty of Medicine, Homburg\/Saar,\n                    Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfgang","family":"Retz","sequence":"additional","affiliation":[{"name":"Institute for Forensic Psychology and Psychiatry,\n                    Saarland University Faculty of Medicine, Homburg\/Saar,\n                    Germany"},{"name":"Department of Psychiatry and Psychotherapy, University\n                    Medical Center Mainz, Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Jacob","sequence":"additional","affiliation":[{"name":"Clinic for Psychiatry and Psychotherapy, Medius Clinic,\n                    Kirchheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Colla","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Psychotherapy and Psychosomatics,\n                    Psychiatric Hospital, University of Zurich, Zurich,\n                    Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Huss","sequence":"additional","affiliation":[{"name":"Department of Child and Adolescent Psychiatry and\n                    Psychotherapy, University Medicine Mainz, Mainz,\n                    Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Jans","sequence":"additional","affiliation":[{"name":"University Hospital of W\u00fcrzburg, Center of Mental\n                    Health, Department of Child and Adolescent Psychiatry,\n                    Psychosomatics and Psychotherapy, W\u00fcrzburg,\n                    Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2020,10,5]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"1199","DOI":"10.1001\/jamapsychiatry.2015.2146","article-title":"Effects of group psychotherapy, individual counseling, methylphenidate, and\n                    placebo in the treatment of adult attention-deficit\/hyperactivity\n                    disorder a randomized clinical trial","volume":"72","author":"A Philipsen","year":"2015","journal-title":"JAMA Psychiat"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1177\/1087054717720718","article-title":"Effectiveness of psychotherapy in adult ADHD: what do patients think? Results of\n                    the COMPAS Study","author":"V Gross","year":"2017","journal-title":"J Atten Disord"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1177\/014107689108400612","article-title":"Spontaneous adverse drug reaction reporting vs. event monitoring: A\n                    comparison","volume":"84","author":"AP Fletcher","year":"1991","journal-title":"J R Soc Med"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"CD009885","DOI":"10.1002\/14651858.CD009885.pub2","article-title":"Methylphenidate for children and adolescents with attention deficit\n                    hyperactivity disorder (ADHD)","author":"O J Storebo","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"ref5","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1007\/s00213-015-4099-3","article-title":"Efficacy, safety and variability in pharmacotherapy for adults with attention\n                    deficit hyperactivity disorder: A meta-analysis and meta-regression in over 9000\n                    patients","volume":"233","author":"R Cunill","year":"2016","journal-title":"Psychopharmacol (Berl)"},{"key":"ref6","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1007\/s00406-014-0522-8","article-title":"Assessment of potential cardiovascular risks of methylphenidate in comparison\n                    with sibutramine: Do we need a SCOUT (trial)?","volume":"265","author":"J Antel","year":"2015","journal-title":"Eur Arch Psychiatry Clin Neurosci"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"537","DOI":"10.1089\/cap.2015.0218","article-title":"Reports of perceived adverse events of stimulant medication on cognition,\n                    motivation, and mood: Qualitative investigation and the generation of items for\n                    the medication and cognition rating scale","volume":"26","author":"H Kovshoff","year":"2016","journal-title":"J Child Adolesc Psychopharmacol"},{"key":"ref8","doi-asserted-by":"crossref","first-page":"286","DOI":"10.1002\/cpp.1765","article-title":"How to define, find and classify side effects in psychotherapy: From unwanted\n                    events to adverse treatment reactions","volume":"20","author":"M Linden","year":"2013","journal-title":"Clin Psychol Psychother"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"208","DOI":"10.1192\/bjp.bp.115.169060","article-title":"Psychotherapies should be assessed for both benefit and harm","volume":"208","author":"J Scott","year":"2016","journal-title":"Br J Psychiatry"},{"key":"ref10","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1037\/a0017299","article-title":"How would we know if psychotherapy were harmful?","volume":"65","author":"S Dimidjian","year":"2010","journal-title":"Am Psychol"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"219","DOI":"10.1007\/s10608-018-9904-y","article-title":"Unwanted events and side effects in cognitive behavior therapy","volume":"42","author":"M-L Schermuly-Haupt","year":"2018","journal-title":"Cognit Ther Res"},{"key":"ref12","first-page":"177","article-title":"Psychotherapy of attention deficit hyperactivity disorder in adults. Eur Arch\n                    Psychiatry Clin","volume":"252","author":"B Hesslinger","year":"2002","journal-title":"Neuroscience"},{"key":"ref13","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1016\/j.brat.2011.01.001","article-title":"Reduced ADHD symptoms in adults with ADHD after structured skills training\n                    group: Results from a randomized controlled trial","volume":"49","author":"T Hirvikoski","year":"2011","journal-title":"Behav Res Ther"},{"key":"ref14","doi-asserted-by":"crossref","first-page":"1013","DOI":"10.1097\/NMD.0b013e31815c088b","article-title":"Structured group psychotherapy in adults with attention deficit hyperactivity\n                    disorder","volume":"195","author":"A Philipsen","year":"2007","journal-title":"J Nerv Ment Dis"},{"key":"ref15","volume-title":"Psychotherapie der ADHS im Erwachsenenalter: Ein Arbeitsbuch","author":"B Hesslinger","year":"2004"},{"key":"ref16","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1007\/s12402-013-0120-z","article-title":"A randomized controlled multicenter trial on the multimodal treatment of adult\n                    attention-deficit hyperactivity disorder: Enrollment and characteristics of the\n                    study sample","volume":"6","author":"A Philipsen","year":"2014","journal-title":"Atten Defic Hyperact Disord"},{"key":"ref17","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1007\/s12402-010-0046-7","article-title":"Evaluation of the efficacy and effectiveness of a structured disorder tailored\n                    psychotherapy in ADHD in adults: Study protocol of a randomized controlled\n                    multicentre trial","volume":"2","author":"A Philipsen","year":"2010","journal-title":"Atten Defic Hyperact Disord"},{"key":"ref18","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1016\/S1386-5056(00)00062-9","article-title":"The use of a medical dictionary for regulatory activities terminology (MedDRA)\n                    in prescription-event monitoring in Japan (J-PEM)","volume":"57","author":"M Yokotsuka","year":"2000","journal-title":"Int J Med Inform"},{"key":"ref19","doi-asserted-by":"crossref","first-page":"109","DOI":"10.2165\/00002018-199920020-00002","article-title":"The medical dictionary for regulatory activities (MedDRA)","volume":"20","author":"E G Brown","year":"1999","journal-title":"Drug Saf"},{"key":"ref21","doi-asserted-by":"crossref","first-page":"873","DOI":"10.1002\/(SICI)1097-0258(19980430)17:8<873::AID-SIM779>3.0.CO;2-I","article-title":"Interval estimation for the difference between independent proportions:\n                    Comparison of eleven methods","volume":"17","author":"RG Newcombe","year":"1998","journal-title":"Stat Med"},{"key":"ref23","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1007\/s40263-015-0241-3","article-title":"Efficacy of methylphenidate hydrochloride extended-release capsules (Aptensio\n                    XR) in children and adolescents with attention-deficit\/hyperactivity\n                    disorder: A phase III, randomized, double-blind study","volume":"29","author":"S B Wigal","year":"2015","journal-title":"CNS Drugs"},{"key":"ref24","first-page":"30S","article-title":"A Review of psychostimulants for adults with depression","volume":"32","author":"R Pary","year":"2015","journal-title":"Fed Pract"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbi.2019.06.006","article-title":"Dopamine-mediated immunomodulation affects choroid plexus function","author":"G Castellani","year":"2019","journal-title":"Brain Behav Immun"},{"key":"ref27","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1186\/s13643-015-0005-7","article-title":"The pharmacological and non-pharmacological treatment of attention deficit\n                    hyperactivity disorder in children and adolescents: protocol for a systematic\n                    review and network meta-analysis of randomized controlled trials","volume":"4","author":"F Catala-Lopez","year":"2015","journal-title":"Syst Rev"},{"key":"ref28","doi-asserted-by":"crossref","first-page":"387","DOI":"10.1007\/s12402-013-0113-y","article-title":"A non-interventional study of extended-release methylphenidate in the routine\n                    treatment of adolescents with ADHD: effectiveness, safety and adherence to\n                    treatment","volume":"5","author":"E Sobanski","year":"2013","journal-title":"Atten Defic Hyperact Disord"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"CD007990","DOI":"10.1002\/14651858.CD007990.pub2","article-title":"Pharmacological treatment for Attention deficit hyperactivity disorder (ADHD) in\n                    children with comorbid tic disorders","author":"T Pringsheim","year":"2011","journal-title":"Cochrane Database Syst Rev"},{"key":"ref30","doi-asserted-by":"crossref","first-page":"377","DOI":"10.1089\/cap.2009.0106","article-title":"A double-blind, randomized, placebo\/active controlled crossover\n                    evaluation of the efficacy and safety of Ritalin (R) LA in children with\n                    attention-deficit\/hyperactivity disorder in a laboratory classroom\n                    setting","volume":"20","author":"E Schulz","year":"2010","journal-title":"J Child Adolesc Psychopharmacol"},{"key":"ref31","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1016\/S2215-0366(18)30269-4","article-title":"Comparative efficacy and tolerability of medications for attention-deficit\n                    hyperactivity disorder in children, adolescents, and adults: A systematic review\n                    and network meta-analysis","volume":"5","author":"S Cortese","year":"2018","journal-title":"Lancet Psychiatry"},{"key":"ref32","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1111\/jcpp.12036","article-title":"Practitioner review: current best practice in the management of adverse events\n                    during treatment with ADHD medications in children and adolescents","volume":"54","author":"S Cortese","year":"2013","journal-title":"J Child Psychol Psychiatry"}],"container-title":["Pharmacopsychiatry"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-1207-9851.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,11,9]],"date-time":"2020-11-09T18:53:21Z","timestamp":1604948001000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-1207-9851"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,5]]},"references-count":29,"journal-issue":{"issue":"06","published-online":{"date-parts":[[2020,11,9]]},"published-print":{"date-parts":[[2020,11]]}},"URL":"https:\/\/doi.org\/10.1055\/a-1207-9851","relation":{},"ISSN":["0176-3679","1439-0795"],"issn-type":[{"value":"0176-3679","type":"print"},{"value":"1439-0795","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10,5]]}}}