褪黑素对急性冠状动脉综合征患者抑郁症状和焦虑的影响：MEDACIS随机临床试验。
The effect of melatonin on depressive symptoms and anxiety in patients after acute coronary syndrome: The MEDACIS randomized clinical trial.
作者信息
Madsen Michael Tvilling, Zahid Jawad Ahmad, Hansen Christine Hangaard, Grummedal Ole, Hansen Jessica Roberts, Isbrand Anders, Andersen Ulla Overgaard, Andersen Lars Juel, Taskiran Mustafa, Simonsen Erik, Gögenur Ismail
机构信息
Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark; Department of Cardiology, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark; Department of Cardiology, Holbaek Hospital, Smedelundsgade 60, 4300, Holbaek, Denmark; Department of Cardiology, Zealand University Hospital, Koegevej 7-13, 4000, Roskilde, Denmark; Department of Cardiology, Slagelse Sygehus, Ingemannsvej 18, 4200, Slagelse, Denmark; Department of Cardiology, Hvidovre Hospital, Kettegaard Alle 30, 2650, Hvidovre, Denmark; Psychiatric Research Unit, Region Zealand, Faelledvej 6, 4200, Slagelse, Denmark; Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark.
出版信息
J Psychiatr Res. 2019 Dec;119:84-94. doi: 10.1016/j.jpsychires.2019.09.014. Epub 2019 Sep 30.
BACKGROUND
Depression following acute coronary syndrome is prevalent and associated with increased mortality and morbidity. Melatonin may function as a primary prophylactic antidepressant substance and alleviate depressive symptoms. The study was undertaken to determine if melatonin administered following an acute coronary syndrome (ACS) could prevent development of depression.
METHODS
The study was a double-blinded, placebo-controlled, multicenter, randomized clinical trial performed in five primary care cardiology departments at Zealand, Denmark. Included patients were adults patients, free of depression at baseline, included at the latest 4 weeks after acute coronary syndrome. Twenty-five mg melatonin or placebo was administered 1 h before participants' bedtime for 12 weeks. The primary outcome is Major Depression Inventory (MDI) measured every two weeks throughout the trial. Incidence of depression was apriori defined as MDI score ≥ 21 during the trial. Reported exploratory outcomes were patterns of dropout and safety outcomes.
RESULTS
1220 patients were screened and 252 participants were randomized in a 1:1 ratio. Baseline MDI score in the melatonin and placebo group were, respectively, 6.18 (CI 5.32-7.05) and 5.98 (CI 5.19-6.77). No significant intergroup differences were found during the study in the intention-to-treat analysis or per-protocol analysis. Cumulative events of depressive episodes during the 12 weeks were six in the melatonin group and four in the placebo group. A significant drop in depressive symptoms were present throughout the study period. No intergroup differences were present in dropouts or adverse events.
CONCLUSIONS
Melatonin showed no prophylactic antidepressant effect following acute coronary syndrome. The non-significant results might be due to a type II error or melatonin might not be able to prevent development of depressive symptoms following ACS.
背景
急性冠状动脉综合征后抑郁症很常见，且与死亡率和发病率增加相关。褪黑素可能作为一种主要的预防性抗抑郁物质，减轻抑郁症状。本研究旨在确定急性冠状动脉综合征（ACS）后给予褪黑素是否能预防抑郁症的发生。
方法
本研究是一项双盲、安慰剂对照、多中心、随机临床试验，在丹麦西兰岛的五个基层心血管病科进行。纳入的患者为成年患者，基线时无抑郁症，在急性冠状动脉综合征后最晚4周纳入。在参与者睡前1小时给予25毫克褪黑素或安慰剂，持续12周。主要结局是在整个试验期间每两周测量一次的主要抑郁量表（MDI）。抑郁症的发生率在试验前定义为MDI评分≥21。报告的探索性结局是脱落模式和安全性结局。
结果
筛选了1220名患者，252名参与者按1:1的比例随机分组。褪黑素组和安慰剂组的基线MDI评分分别为6.18（CI 5.32 - 7.05）和5.98（CI 5.19 - 6.77）。在意向性分析或符合方案分析中，研究期间未发现显著的组间差异。褪黑素组在12周内抑郁发作的累积事件为6例，安慰剂组为4例。在整个研究期间抑郁症状有显著下降。在脱落或不良事件方面不存在组间差异。
结论
急性冠状动脉综合征后，褪黑素未显示出预防性抗抑郁作用。结果不显著可能是由于II型错误，或者褪黑素可能无法预防急性冠状动脉综合征后抑郁症状的发生。
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