| 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
|
|---|---|
| Published in |
Trials, February 2017
|
| DOI | 10.1186/s13063-017-1806-x |
| Pubmed ID | |
| Authors |
Michael Tvilling Madsen, Anders Isbrand, Ulla Overgaard Andersen, Lars Juel Andersen, Mustafa Taskiran, Erik Simonsen, Ismail Gögenur |
| 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. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Turkey | 1 | 50% |
| United States | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 81 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Austria | 1 | 1% |
| Unknown | 80 | 99% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 13 | 16% |
| Student > Master | 12 | 15% |
| Student > Ph. D. Student | 8 | 10% |
| Student > Doctoral Student | 7 | 9% |
| Student > Bachelor | 5 | 6% |
| Other | 11 | 14% |
| Unknown | 25 | 31% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 19 | 23% |
| Psychology | 8 | 10% |
| Nursing and Health Professions | 7 | 9% |
| Biochemistry, Genetics and Molecular Biology | 4 | 5% |
| Neuroscience | 4 | 5% |
| Other | 10 | 12% |
| Unknown | 29 | 36% |