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

• Status: Completed
• Trial end date: 2018-07-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Collaborators: Pharma Nord; Psychiatric Research Unit, Region Zealand, Denmark; University of Copenhagen
• Treatments: Melatonin

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

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 ( e.g. 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).

For the MEFACS subtrial - (single center)

15. Conditions that preclude/make impossible the measurement of reliable RHI (e.g. patient with only one arm, known side-difference in brachial arterial blood pressure and other factors).