Department of Psychiatry, Psychotherapy and Psychosomatics, St. Elisabeth Hospital Niederwenigern, Contilia Group, Hattingen, Germany.
Department of Psychiatry and Psychotherapy, University Medical Center, Göttingen, Germany.
Pharmacopsychiatry. 2020 Nov;53(6):263-271. doi: 10.1055/a-1207-9851. Epub 2020 Oct 5.
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.
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.
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.
In this so far longest-running clinical trial, methylphenidate treatment was safe and well-tolerated.
成人注意缺陷多动障碍比较研究（COMPAS）是一项前瞻性、随机、多中心临床试验，比较了哌醋甲酯（MPH）与安慰剂（PLAC）联合认知行为团体心理治疗（GPT）或个体临床管理（CM）在 1 年期间的效果。这里，我们报告治疗安全性的结果。
MPH 和 PLAC 均灵活给药。在 433 名随机患者中，在第 0-52 周记录不良事件（AE）并根据“实际接受”进行分析。在基线和第 24 周记录心电图数据。
与接受≥1 剂 MPH 的 205 名患者相比，接受 PLAC 的 209 名患者中，MPH 组发生的 AE 明显更多，包括食欲减退（22 例 vs. 3.8%）、口干（15 例 vs. 4.8%）、心悸（13 例 vs. 3.3%）、胃肠感染（11 例 vs. 4.8%）、激越（11 例 vs. 3.3%）、不安（10 例 vs. 2.9%）、多汗、心动过速、体重减轻（均 6.3% vs. 1.9%）、抑郁症状、流感（均 4.9% vs. 1.0%）和急性扁桃体炎（4.4% vs. 0.5%）。PLAC 组晕厥发生率明显更高（2.4% vs. 0%）。两组均很少发生临床相关的心电图变化。严重 AE 罕见且无明显组间差异。接受 GPT 治疗的 206 例患者与接受 CM 治疗的 209 例患者的比较没有发现主要差异。CM 组有 5 例严重 AE 被归类为精神科，GPT 组有 1 例。
在这项迄今为止持续时间最长的临床试验中，哌醋甲酯治疗是安全且耐受良好的。
