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

Author:

Kis Bernhard123,Lücke Caroline4,van Elst Ludger Tebartz5,Müller Helge H. O.6,Philipsen Alexandra4,Abdel-Hamid Mona23,Heßmann Philipp2,Graf Erika7,Berger Mathias5,Matthies Swantje5,Borel Patricia5,Sobanski Esther89,Alm Barbara8,Rösler Michael10,Retz Wolfgang1011,Jacob Christian12,Colla Michael13,Huss Michael9,Jans Thomas14

Affiliation:

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

4. Department of Psychiatry and Psychotherapy – University of Bonn, Bonn, Germany

5. Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center – University of Freiburg, Freiburg, Germany

6. Witten/Herdecke University, Faculty of Health/School of Medicine, Integrative Psychiatry and Psychotherapy, Witten, Germany

7. Institute of Medical Biometry and Statistics, Clinical Trials Unit and Medical Faculty, University Medical Center – University of Freiburg, Freiburg, Germany

8. Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany

9. Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany

10. Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany

11. Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany

12. Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany

13. Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland

14. University Hospital of Würzburg, Center of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Würzburg, Germany

Abstract

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.

Funder

German Federal Ministry of Research and Education

German network for the treatment of ADHD in children and adults

MEDICE Arzneimittel Puetter GmbH and Co KG

Publisher

Georg Thieme Verlag KG

Subject

Pharmacology (medical),Psychiatry and Mental health,General Medicine

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