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

Phase 1

• Conditions: DepressionAnxietySleep disturbancesCircadian disturbances; MedDRA version: 19.0Level: LLTClassification code 10009190Term: Circadian dysrhythmiaSystem Organ Class: 100000004852; MedDRA version: 19.0Level: LLTClassification code 10002865Term: Anxiety reactionSystem Organ Class: 100000004873; MedDRA version: 19.0Level: LLTClassification code 10040999Term: Sleep disturbedSystem Organ Class: 100000004873; MedDRA version: 19.0Level: LLTClassification code 10012402Term: Depressive episodeSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002116-32-DK
• Lead Sponsor: Køge Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-10
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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. 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

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 (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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified