Insomnia because of disturbed sleep-work-rhythm MedDRA version: 17.0 Level: LLT Classification code 10032168 Term: Other insomnia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 17.0 Level: PT Classification code 10022443 Term: Insomnia related to another mental condition System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Circadin
Pharmaceutical Form: Prolonged-release tablet
CAS Number: 73-31-4
Other descriptive name: MELATONIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Ability to understand and personally sign and date the in-formed consent to participate in the study before completing any study related procedures. 2.White male and female above the age of 18 years inclusive at the time of consent. 3.Night shift workers on regular night shifts with at least 4 night shifts per month during the study period. Subjects must have been on regular night shifts for at least 6 months before inclusion into the study. 4.The subject is co-operative and available for the entire study. 5. Signed and written informed consent. 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.Pregnancy or breast feeding. 2.Current or relevant history of physical or psychiatric illness that makes the subject unlikely to fully complete the study, or any condition that presents undue risk from the study procedures. 3.Known autoimmune disease. 4.Evidence of relevant renal insufficiency as indicated by an estimated glomerular filtration rate below 60 ml/min. 5.Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as ALT, AST, GGT, alkaline phosphatase, or serum bilirubin. 6.Known or suspected intolerance or hypersensitivity to the study medication, closely related compounds, or any of the stated ingredients. 7.Current or history of hereditary galactose-intolerance, lapp-lactose-deficiency or glucose-galactose-malabsorption. 8.Use of melatonin, fluvoxamine, cimetidine, quinolones, car-bamazepine, rifampicine, 5-methoxypsoralene or 8-methoxypsoralene within 4 weeks prior to the inclusion into the study. 9.Long distance travel over more than 3 time zones within 4 weeks prior to study inclusion. 10.Subjects who consume more than 750 mg per day caffeine. 11.Donation of blood or blood products (e.g., 450 mL or more of plasma or platelets) within 60 days prior to inclusion into the study. 12.Inability or difficulties to swallow all investigational medicinal products. 13.Participation in a clinical investigation within the past 4 weeks before first administration of IMP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in night shift workers the efficacy of melatonin over 12 weeks to a) improve metabolic control and b) regulate expression patterns of genes involved in the regulation of metabolism and circadian rhythm ;Secondary Objective: To provide data on the interaction between genes, epigenetics, metabolism, cardiovascular function and the internal clock in order to identify novel biomarkers and genes of interest for future therapeutic approaches in targeting circadian rhythms of metabolic control.;Primary end point(s): The change in the area under the curve (AUC) of blood glucose during an oral glucose tolerance test between baseline and 12 weeks of intervention within groups.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The change in the area under the curve (AUC) of blood glu-cose during an oral glucose tolerance test between week 12 and week 24 (= after 12 weeks without intervention). •The change in the area under the curve (AUC) of blood insu-lin during an oral glucose tolerance test between baseline and 12 weeks of intervention. •The change in the area under the curve (AUC) of blood insu-lin during an oral glucose tolerance test between week 12 and week 24 (= after 12 weeks without intervention). •The change in indices of glucose homeostasis (HOMA, QUICKI index, Stumvoll-ISI index, HbA1c) between baseline and 12 weeks of intervention. •The difference in the above-mentioned parameters of metabolic control between intervention and control at 12 weeks of intervention and at 24 weeks. •The change in body weight, BMI, abdominal circumference, biomarkers and vascular function between baseline and 12 weeks of intervention and between week 12 and 24. •The change in the gene expression patterns of Clock genes in peripheral blood monocytic cells (PBMC) between base-line and 12 weeks of intervention and between week 12 and 24. •The differences in epigenetic profiles of genes involved in circadian rhythm between the study groups after 12 weeks of intervention and between week 12 and 24. •The differences in plasma and serum biomarkers between baseline and 12 weeks of intervention and between week 12 and 24. ;Timepoint(s) of evaluation of this end point: Week 12 Week 24 | — |
Countries
Germany, Italy, United Kingdom
Contacts
Public ContactRainer Boeger
Department of Clinical Pharmacology and Toxicology
Outcome results
None listed