The effect of melatonin on depressive symptoms and anxiety in patients after acute coronary syndrome: The MEDACIS randomized clinical trial.

Autor: Madsen MT; 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. Electronic address: michael_madsen88@hotmail.com., Zahid JA; Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. Electronic address: ja_zahid@yahoo.dk., Hansen CH; Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. Electronic address: christine.hangaard@gmail.com., Grummedal O; Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. Electronic address: olegrummedal@gmail.com., Hansen JR; Psychiatric Research Unit, Region Zealand, Faelledvej 6, 4200, Slagelse, Denmark. Electronic address: jfernisr1@gmail.com., Isbrand A; Department of Clinical Physiology and Nuclear Medicine, Herlev Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark. Electronic address: andersisbrand@gmail.com., Andersen UO; Department of Cardiology, Holbaek Hospital, Smedelundsgade 60, 4300, Holbaek, Denmark. Electronic address: uoa@regionsjaelland.dk., Andersen LJ; Department of Cardiology, Zealand University Hospital, Koegevej 7-13, 4000, Roskilde, Denmark. Electronic address: laad@regionsjaelland.dk., Taskiran M; Department of Cardiology, Hvidovre Hospital, Kettegaard Alle 30, 2650, Hvidovre, Denmark. Electronic address: mustafa.taskiran.01@regionh.dk., Simonsen E; 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. Electronic address: es@regionsjaelland.dk., Gögenur I; Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark; Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: igo@regionsjaelland.dk.
Jazyk: angličtina
Zdroj: Journal of psychiatric research [J Psychiatr Res] 2019 Dec; Vol. 119, pp. 84-94. Date of Electronic Publication: 2019 Sep 30.
DOI: 10.1016/j.jpsychires.2019.09.014
Abstrakt: 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.
(Copyright © 2019 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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