Pharmacopsychiatry 2020; 53(06): 263-271
DOI: 10.1055/a-1207-9851
Original Paper

Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients – Results of the COMPAS Study

Bernhard Kis
1  Department of Psychiatry, Psychotherapy and Psychosomatics, St. Elisabeth Hospital Niederwenigern, Contilia Group, Hattingen, Germany
2  Department of Psychiatry and Psychotherapy, University Medical Center, Göttingen, Germany
3  LVR-Hospital Essen, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
,
Caroline Lücke
4  Department of Psychiatry and Psychotherapy – University of Bonn, Bonn, Germany
,
Mona Abdel-Hamid
2  Department of Psychiatry and Psychotherapy, University Medical Center, Göttingen, Germany
3  LVR-Hospital Essen, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
,
Philipp Heßmann
2  Department of Psychiatry and Psychotherapy, University Medical Center, Göttingen, Germany
,
Erika Graf
5  Institute of Medical Biometry and Statistics, Clinical Trials Unit and Medical Faculty, University Medical Center – University of Freiburg, Freiburg, Germany
,
Mathias Berger
6  Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center – University of Freiburg, Freiburg, Germany
,
Swantje Matthies
6  Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center – University of Freiburg, Freiburg, Germany
,
Patricia Borel
6  Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center – University of Freiburg, Freiburg, Germany
,
Esther Sobanski
7  Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany
8  Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany
,
Barbara Alm
7  Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany
,
Michael Rösler
9  Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany
,
Wolfgang Retz
9  Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany
10  Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany
,
Christian Jacob
11  Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany
,
Michael Colla
12  Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland
,
Michael Huss
8  Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany
,
Thomas Jans
13  University Hospital of Würzburg, Center of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Würzburg, Germany
,
Ludger Tebartz van Elst
6  Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center – University of Freiburg, Freiburg, Germany
,
Helge H. O. Müller
14  Witten/Herdecke University, Faculty of Health/School of Medicine, Integrative Psychiatry and Psychotherapy, Witten, Germany
,
Alexandra Philipsen
4  Department of Psychiatry and Psychotherapy – University of Bonn, Bonn, Germany
› Author Affiliations
Funding: The COMPAS trial was funded by the German Federal Ministry of Research and Education (01GV0606) and is part of the German network for the treatment of ADHD in children and adults (ADHD-NET). The trial medication (Medikinet retard, licensed as Medikinet adult, and matching placebo) was provided by MEDICE Arzneimittel Puetter GmbH and Co KG.

Abstract

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.

Supporting Information



Publication History

Received: 12 December 2019
Received: 13 May 2020

Accepted: 19 June 2020

Publication Date:
05 October 2020 (online)

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