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

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@article{af59745106994700a7132e6307a6fc83,
title = "The effect of melatonin on depressive symptoms and anxiety in patients after acute coronary syndrome: The MEDACIS randomized clinical trial",
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.",
keywords = "Acute coronary syndrome, Depression, Melatonin, Placebo, Primary prophylactic, Randomized controlled trial",
author = "Madsen, {Michael Tvilling} and Zahid, {Jawad Ahmad} and Hansen, {Christine Hangaard} and Ole Grummedal and Hansen, {Jessica Roberts} and Anders Isbrand and Andersen, {Ulla Overgaard} and Andersen, {Lars Juel} and Mustafa Taskiran and Erik Simonsen and Ismail G{\"o}genur",
note = "Copyright {\textcopyright} 2019 Elsevier Ltd. All rights reserved.",
year = "2019",
month = dec,
doi = "10.1016/j.jpsychires.2019.09.014",
language = "English",
volume = "119",
pages = "84--94",
journal = "Journal of Psychiatric Research",
issn = "0022-3956",
publisher = "Pergamon",

}

RIS

TY - JOUR

T1 - The effect of melatonin on depressive symptoms and anxiety in patients after acute coronary syndrome

T2 - The MEDACIS randomized clinical trial

AU - Madsen, Michael Tvilling

AU - Zahid, Jawad Ahmad

AU - Hansen, Christine Hangaard

AU - Grummedal, Ole

AU - Hansen, Jessica Roberts

AU - Isbrand, Anders

AU - Andersen, Ulla Overgaard

AU - Andersen, Lars Juel

AU - Taskiran, Mustafa

AU - Simonsen, Erik

AU - Gögenur, Ismail

N1 - Copyright © 2019 Elsevier Ltd. All rights reserved.

PY - 2019/12

Y1 - 2019/12

N2 - 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.

AB - 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.

KW - Acute coronary syndrome

KW - Depression

KW - Melatonin

KW - Placebo

KW - Primary prophylactic

KW - Randomized controlled trial

UR - http://www.scopus.com/inward/record.url?scp=85072777364&partnerID=8YFLogxK

U2 - 10.1016/j.jpsychires.2019.09.014

DO - 10.1016/j.jpsychires.2019.09.014

M3 - Journal article

C2 - 31586772

VL - 119

SP - 84

EP - 94

JO - Journal of Psychiatric Research

JF - Journal of Psychiatric Research

SN - 0022-3956

ER -

ID: 58108961