title: 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.
abstract: Depression 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.
  
  
  
  "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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov, Identifier: NCT02451293 . Registered on 12 May 2015. EudraCT nr. 2015-002116-32.
authors.affiliation: Department of Surgery, Zealand University Hospital, University of Copenhagen, Lykkebaekvej 1, 4600, Koege, Denmark. michael_madsen88@hotmail.com.|Department of Cardiology, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. michael_madsen88@hotmail.com.|Department of Cardiology, Holbaek Hospital, Smedelundsgade 60, 4300, Holbaek, Denmark. michael_madsen88@hotmail.com.|Department of Cardiology, Zealand University Hospital, Roskilde, Koegevej 7-13, 4000, Roskilde, Denmark. michael_madsen88@hotmail.com.|Psychiatric Research Unit, Region Zealand, Faelledvej 6, Bygning 3, 4. Sal., 4200, Slagelse, Denmark. michael_madsen88@hotmail.com.
authors.forename: Michael Tvilling
authors.initials: MT
authors.lastname: Madsen
authors.affiliation: Department of Cardiology, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark.
authors.forename: Anders
authors.initials: A
authors.lastname: Isbrand
authors.affiliation: Department of Cardiology, Holbaek Hospital, Smedelundsgade 60, 4300, Holbaek, Denmark.
authors.forename: Ulla Overgaard
authors.initials: UO
authors.lastname: Andersen
authors.affiliation: Department of Cardiology, Zealand University Hospital, Roskilde, Koegevej 7-13, 4000, Roskilde, Denmark.
authors.forename: Lars Juel
authors.initials: LJ
authors.lastname: Andersen
authors.affiliation: Department of Cardiology, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark.
authors.forename: Mustafa
authors.initials: M
authors.lastname: Taskiran
authors.affiliation: Psychiatric Research Unit, Region Zealand, Faelledvej 6, Bygning 3, 4. Sal., 4200, Slagelse, Denmark.|Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Erik
authors.initials: E
authors.lastname: Simonsen
authors.affiliation: Department of Surgery, Zealand University Hospital, University of Copenhagen, Lykkebaekvej 1, 4600, Koege, Denmark.|Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Ismail
authors.initials: I
authors.lastname: Gögenur
mesh_terms: D054058:Acute Coronary Syndrome / Q000150:complications*; D001007:Anxiety / Q000517:prevention & control*; D002940:Circadian Rhythm / Q000187:drug effects*; D002985:Clinical Protocols; D003863:Depression / Q000517:prevention & control*; D004311:Double-Blind Method; D006801:Humans; D008550:Melatonin / Q000009:adverse effects / Q000627:therapeutic use*; D012893:Sleep Wake Disorders / Q000517:prevention & control*
chemical_list: D008550:Melatonin
keywords: Acute coronary syndrome; Anxiety; Circadian rhythm; Depression; Melatonin; Sleep disturbances