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

Michael Tvilling Madsen; Jawad Ahmad Zahid; Christine Hangaard Hansen; Ole Grummedal; Jessica Roberts Hansen; Anders Isbrand; Ulla Overgaard Andersen; Lars Juel Andersen; Mustafa Taskiran; Erik Simonsen; Ismail Gögenur

doi:10.1016/j.jpsychires.2019.09.014

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

Michael Tvilling Madsen^*, Jawad Ahmad Zahid, Christine Hangaard Hansen, Ole Grummedal, Jessica Roberts Hansen, Anders Isbrand, Ulla Overgaard Andersen, Lars Juel Andersen, Mustafa Taskiran, Erik Simonsen, Ismail Gögenur

^*Corresponding author for this work

2 Citations (Scopus)

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.

Original language	English
Journal	Journal of Psychiatric Research
Volume	119
Pages (from-to)	84-94
Number of pages	11
ISSN	0022-3956
DOIs	https://doi.org/10.1016/j.jpsychires.2019.09.014
Publication status	Published - Dec 2019

Keywords

Acute coronary syndrome
Depression
Melatonin
Placebo
Primary prophylactic
Randomized controlled trial

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10.1016/j.jpsychires.2019.09.014

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Madsen, M. T., Zahid, J. A., Hansen, C. H., Grummedal, O., Hansen, J. R., Isbrand, A., Andersen, U. O., Andersen, L. J., Taskiran, M., Simonsen, E., & Gögenur, I. (2019). The effect of melatonin on depressive symptoms and anxiety in patients after acute coronary syndrome: The MEDACIS randomized clinical trial. Journal of Psychiatric Research, 119, 84-94. https://doi.org/10.1016/j.jpsychires.2019.09.014

The effect of melatonin on depressive symptoms and anxiety in patients after acute coronary syndrome : The MEDACIS randomized clinical trial. / Madsen, Michael Tvilling; Zahid, Jawad Ahmad; Hansen, Christine Hangaard et al.

In: Journal of Psychiatric Research, Vol. 119, 12.2019, p. 84-94.

Research output: Contribution to journal › Journal article › Research › peer-review

Madsen, MT, Zahid, JA, Hansen, CH, Grummedal, O, Hansen, JR, Isbrand, A, Andersen, UO, Andersen, LJ, Taskiran, M , Simonsen, E & Gögenur, I 2019, 'The effect of melatonin on depressive symptoms and anxiety in patients after acute coronary syndrome: The MEDACIS randomized clinical trial', Journal of Psychiatric Research, vol. 119, pp. 84-94. https://doi.org/10.1016/j.jpsychires.2019.09.014

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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{\textquoteright} 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",

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 Press",

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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

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

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U2 - 10.1016/j.jpsychires.2019.09.014

DO - 10.1016/j.jpsychires.2019.09.014

M3 - Journal article

C2 - 31586772

AN - SCOPUS:85072777364

SN - 0022-3956

VL - 119

SP - 84

EP - 94

JO - Journal of Psychiatric Research

JF - Journal of Psychiatric Research

ER -

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

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Keywords

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