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

NCT02451293 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2019-01-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Melatonin (N-acetyl-5-methoxytryptamine)

DRUG

Placebo

Sponsors & Collaborators

  • Psychiatric Research Unit, Region Zealand, Denmark

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Pharma Nord

    collaborator INDUSTRY

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Michael Tvilling Madsen, M.D. · Department of surgery. Koege and Roskilde Hospital

  • Ismail Gögenur, M.D. Professor · Department of surgery. Koege and Roskilde Hospital

  • Erik Simonsen, M.D. Professor · Psychiatric Research Unit, Region Zealand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-18
Primary Completion
2017-08-18
Completion
2018-07-20

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02451293 on ClinicalTrials.gov