drugset / Trial / NCT02451293
The Effect of MElatonin on Depression, Anxiety, CIrcadian and Sleep Disturbances in Patients After Acute Myocardial Syndrome
Phase 2/3
Completed
252 enrolled
Zealand University Hospital
Pharma Nord · collabPsychiatric Research Unit, Region Zealand, Denmark · collabUniversity of Copenhagen · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of the study is to investigate whether prophylactic treatment with melatonin has an effect on depressive symptoms. Secondarily melatonin's effect on anxiety, sleep and circadian disturbances will be investigated. The MEDACIS trial is a randomised, placebo-controlled, double-blinded multicenter trial investigating the effect of 25 mg exogenous melatonin (intervention group) against placebo (control group) and the study is designed as a parallel group superiority trial.
Timeline
- Start
- 2016-01-18
- Primary completion
- 2017-08-18
- Completion
- 2018-07-20
Publications
- Madsen MT, Juel K, Simonsen E, Gogenur I, Zwisler ADO. External validity of randomized clinical trial studying preventing depressive symptoms following acute coronary syndrome. Brain Behav. 2021 Aug;11(8):e02132. doi: 10.1002/brb3.2132. Epub 2021 Jun 17.
- Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3.
- Madsen MT, Isbrand A, Andersen UO, Andersen LJ, Taskiran M, Simonsen E, Gogenur I. 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. Trials. 2017 Feb 23;18(1):81. doi: 10.1186/s13063-017-1806-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Melatonin | Small molecule | 25 mg | Oral |