In:
Pharmacopsychiatry, Georg Thieme Verlag KG, Vol. 53, No. 06 ( 2020-11), p. 263-271
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.
Type of Medium:
Online Resource
ISSN:
0176-3679
,
1439-0795
Language:
English
Publisher:
Georg Thieme Verlag KG
Publication Date:
2020
detail.hit.zdb_id:
2041961-2
SSG:
15,3
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