Michael Tvilling Madsen1, Jawad Ahmad Zahid2, Christine Hangaard Hansen3, Ole Grummedal4, Jessica Roberts Hansen5, Anders Isbrand6, Ulla Overgaard Andersen7, Lars Juel Andersen8, Mustafa Taskiran9, Erik Simonsen10, Ismail Gögenur11. 1. 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. 2. Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. Electronic address: ja_zahid@yahoo.dk. 3. Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. Electronic address: christine.hangaard@gmail.com. 4. Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. Electronic address: olegrummedal@gmail.com. 5. Psychiatric Research Unit, Region Zealand, Faelledvej 6, 4200, Slagelse, Denmark. Electronic address: jfernisr1@gmail.com. 6. Department of Clinical Physiology and Nuclear Medicine, Herlev Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark. Electronic address: andersisbrand@gmail.com. 7. Department of Cardiology, Holbaek Hospital, Smedelundsgade 60, 4300, Holbaek, Denmark. Electronic address: uoa@regionsjaelland.dk. 8. Department of Cardiology, Zealand University Hospital, Koegevej 7-13, 4000, Roskilde, Denmark. Electronic address: laad@regionsjaelland.dk. 9. Department of Cardiology, Hvidovre Hospital, Kettegaard Alle 30, 2650, Hvidovre, Denmark. Electronic address: mustafa.taskiran.01@regionh.dk. 10. 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. 11. 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.
Abstract
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.
RCT Entities:
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.
Authors: Luyan Zhang; Yaling Tian; Hong Ren; Aihong Zhu; Li Dong; Xiuqin Wang; Xiaoyu Han Journal: Comput Math Methods Med Date: 2022-07-21 Impact factor: 2.809