Evidence map›Paper›PMID 28228148›Full record

ArticleTrials2017

The effect of MElatonin on Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome (MEDACIS): study protocol for a randomized controlled trial.

Michael Tvilling Madsen, Anders Isbrand, Ulla Overgaard Andersen, Lars Juel Andersen, Mustafa Taskiran, Erik Simonsen, Ismail Gögenur

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02451293 (The Effect of MElatonin on Depression, Anxiety, CIrcadian and Sleep Disturbances in Patients After Acute Myocardial Syndrome), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02451293 phase2 / phase3completednot on this map

The Effect of MElatonin on Depression, Anxiety, CIrcadian and Sleep Disturbances in Patients After Acute Myocardial Syndrome

TypeinterventionalSponsorZealand University HospitalRan2016 to 2018Enrolled252ConditionsDepression, Acute Coronary SyndromeArmsMelatonin (N-acetyl-5-methoxytryptamine), Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Prevention of depression in adults with long-term physical conditions.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Trial
  3. Trial
  4. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Michael Tvilling MadsenDepartment of Surgery, Zealand University Hospital, University of Copenhagen, Lykkebaekvej 1, 4600, Koege, Denmark. michael_madsen88@hotmail.com.
Anders IsbrandDepartment of Cardiology, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark.
Ulla Overgaard AndersenDepartment of Cardiology, Holbaek Hospital, Smedelundsgade 60, 4300, Holbaek, Denmark.
Lars Juel AndersenDepartment of Cardiology, Zealand University Hospital, Roskilde, Koegevej 7-13, 4000, Roskilde, Denmark.
Mustafa TaskiranDepartment of Cardiology, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark.
Erik SimonsenPsychiatric Research Unit, Region Zealand, Faelledvej 6, Bygning 3, 4. Sal., 4200, Slagelse, Denmark.
Ismail GögenurDepartment of Surgery, Zealand University Hospital, University of Copenhagen, Lykkebaekvej 1, 4600, Koege, Denmark.
Zealand University Hospital · DKHolbæk Sygehus · DKRegion Zealand · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDepression following acute coronary syndrome (ACS) constitutes a serious and debilitating problem. Approximately one in five patients will develop significant depression following ACS and less severe depressive symptoms are even more frequent. Furthermore, anxiety symptoms and sleep-wake disturbances are frequent. The objective of the MEDACIS trial is to investigate whether prophylactic treatment with melatonin has a preventive effect on depression, depressive and anxiety symptoms, sleep, and circadian disturbances following ACS. METHODS/

design"The effect of MElatonin and Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome" trial (MEDACIS) is a multicenter, double-blinded, placebo-controlled, randomized clinical trial. A total of 240 patients with ACS and no depressive symptoms will be included in the trial for treatment with either 25 mg melatonin or placebo for a 12-week period. Development and severity of depressive symptoms will be evaluated using Major Depression Inventory every 2 weeks with the purpose of investigating the potential preventive effect of melatonin on depressive symptoms. DISCUSSION: Previously, only selective serotonin reuptake inhibitors (SSRIs) have been investigated in a primary preventive setup in patients following ACS. However, SSRIs are associated with several side effects. An ideal intervention would constitute the highest degree of prevention of depressive symptoms with the lowest risk of side effects. In this regard, melatonin may have advantages due to its low toxicity as well as its proven anxiolytic and hypnotic effects.

trial registrationClinicalTrials.gov, Identifier: NCT02451293 . Registered on 12 May 2015. EudraCT nr. 2015-002116-32.

Indexed as

Clinical ProtocolsAcute Coronary SyndromeAnxietyCircadian RhythmDepressionDouble-Blind MethodHumansMelatoninSleep Wake DisordersMelatoninAcute coronary syndromeAnxietyCircadian rhythmDepressionMelatoninSleep disturbances

Identifiers

PMID28228148
PMCPMC5322602
OpenAlexW2590768315

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.