The effect of MElatonin on Depression, Anxiety, CIrcadian and Sleep disturbances in patients after acute myocardial syndrome - MEDACIS

Køge Hospital0 个研究点开始时间: 2015年8月10日最近更新: 2017年10月2日

试验速览

暂无简介。

•1.Patients should be admitted to a coronary care unit for acute coronary syndrome (ACS), and should be enrolled within 4 weeks after the primary ACS.
•2.Participants should be 18 years or older.
•3.No sign of depression on Major Depression Inventory (MDI) at the point of enrolment.
•4.Participants must sign an informed consent form
•5.Females not in menopause (defined as no menstruation during the last 12 months) should have a negative pregnancy test. Furthermore, reproductive females should use a secure birth control (intrauterine devices, hormonal contraceptives including – oral pills, patches, vaginal rings and injections) during the entire period of the trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•1.Known allergic reaction to melatonin.
•2.Ongoing or previous pharmacological treated depression or bipolar disorder.
•3.No dementia as determined by mini mental state examination score (MMSE) < 24 (appendix 2)
•4.At the point of inclusion no participation in another pharmacological intervention trial is allowed.
•5.No diagnose of Rotor or Dubin-Johnson syndrome, epilepsy, sleep apnoea syndrome, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) or multiple sclerosis is allowed.
•6.Severe liver disease defined as transaminases above X 3 normal levels, and severe kidney disease defined as eGRF under 40 ml/min.
•7.Ongoing hypnotic treatment.
•8.Known sleep disorder (e.g. insomnia, restless legs etc.)
•9.Work involving nightshifts.
•10.Daily alcohol consumption above 5 units of alcohol (1 unit = 12 g alcohol)
•11.Predictable poor compliance (not speaking fluent Danish)
•12.Pregnant or breastfeeding.
•13.Severe, life-threatening medical condition, that implies that the patient cannot participate in a the study course. (e.g. cancer, stroke, )
•14.Indication for coronary artery bypass graft (CABG).

发起方

Køge Hospital