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

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

  • Kis B Department of Psychiatry, Psychotherapy and Psychosomatics, St. Elisabeth Hospital Niederwenigern, Contilia Group, Hattingen, Germany.
  • Lücke C Department of Psychiatry and Psychotherapy - University of Bonn, Bonn, Germany.
  • Abdel-Hamid M Department of Psychiatry and Psychotherapy, University Medical Center, Göttingen, Germany.
  • Heßmann P Department of Psychiatry and Psychotherapy, University Medical Center, Göttingen, Germany.
  • Graf E Institute of Medical Biometry and Statistics, Clinical Trials Unit and Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.
  • Berger M Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.
  • Matthies S Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.
  • Borel P Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.
  • Sobanski E Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
  • Alm B Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
  • Rösler M Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany.
  • Retz W Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany.
  • Jacob C Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany.
  • Colla M Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.
  • Huss M Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany.
  • Jans T University Hospital of Würzburg, Center of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Würzburg, Germany.
  • van Elst LT Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.
  • Müller HHO Witten/Herdecke University, Faculty of Health/School of Medicine, Integrative Psychiatry and Psychotherapy, Witten, Germany.
  • Philipsen A Department of Psychiatry and Psychotherapy - University of Bonn, Bonn, Germany.
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  • 2020-10-05
Published in:
  • Pharmacopsychiatry. - 2020
English 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.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://folia.unifr.ch/global/documents/22816
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