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Safety profile of Methylphenidate under long-term treatment in Adult ADHD patients$cresults of the COMPAS Study

<p> <b>Introduction</b> 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)...

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Main Authors: Kis, Bernhard (Author) , Lücke, Caroline (Author) , Abdel-Hamid, Mona (Author) , Heßmann, Philipp (Author) , Graf, Erika (Author) , Berger, Mathias (Author) , Matthies, Swantje (Author) , Borel, Patricia (Author) , Sobanski, Esther (Author) , Alm, Barbara (Author) , Rösler, Michael (Author) , Retz, Wolfgang (Author) , Jacob, Christian (Author) , Colla, Michael (Author) , Huss, Michael (Author) , Jans, Thomas (Author) , Elst, Ludger Tebartz van (Author) , Müller, Helge H. O. (Author) , Philipsen, Alexandra (Author)
Format: Article (Journal)
Language:English
Published: 05.10.2020
In: Pharmacopsychiatry
Year: 2020, Volume: 53, Issue: 06, Pages: 263-271
ISSN:1439-0795
DOI:10.1055/a-1207-9851
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1055/a-1207-9851
Verlag, lizenzpflichtig, Volltext: http://www.thieme-connect.de/DOI/DOI?10.1055/a-1207-9851
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Author Notes:Bernhard Kis, Caroline Lücke, Mona Abdel-Hamid, Philipp Heßmann, Erika Graf, Mathias Berger, Swantje Matthies, Patricia Borel, Esther Sobanski, Barbara Alm, Michael Rösler, Wolfgang Retz, Christian Jacob, Michael Colla, Michael Huss, Thomas Jans, Ludger Tebartz van Elst, Helge H.O. Müller, Alexandra Philipsen
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Summary:<p> <b>Introduction</b> 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.</p> <p> <b>Methods</b> 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.</p> <p> <b>Results</b> 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.</p> <p> <b>Conclusion</b> In this so far longest-running clinical trial, methylphenidate treatment was safe and well-tolerated.</p>
Item Description:Gesehen am 17.03.2025
Physical Description:Online Resource
ISSN:1439-0795
DOI:10.1055/a-1207-9851

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