Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr I M van Geijlswijk
ORCID ID
Contact details
University Medical Center Utrecht (UMCU)
Pharmacy of Faculty Animal Medicine
Ede
6716 RP
Netherlands
+31 (0)30 253 2066
i.m.vangeijlswijk@vet.uu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MELDOS VERSION 2.0
Study information
Scientific title
Acronym
MELDOS
Study hypothesis
Chronic sleep disorders are associated with dysfunctioning during the day. Circadian rhythm disorders are a frequently occurring cause of chronic sleep disorders. The time at which the endogenous melatonin production starts to rise plays a key-role in the synchronisation of circadian rhythms. In adults with sleep-wake rhythm disorders and late melatonin onset, exogenous melatonin, when administered at an appropriate time advances both endogenous melatonin onset and sleep-wake rhythm. Pharmacokinetics and side effects of melatonin in children might differ from those in adults. Consequently it is necessary to study the effects of melatonin not only in adults but also in children.
Ethics approval
Approval received from the Medical Ethical Committee of the Utrecht University Hospital (Medisch Ethische Toetsingscommissie van het UMC Utrecht) on the 17th June 2003 (ref: 03/007).
Study design
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Insomnia, Attention Deficit Hyperactivity Disorder (ADHD), sleep disorders
Intervention
The study lasts two weeks. One baseline week, followed by one treatment week with melatonin (commercially available Over The Counter [OTC] product) 0.05 mg/kg, 0.1 mg/kg, 0.15 mg/kg or placebo treatment.
Intervention type
Drug
Phase
Not Applicable
Drug names
Melatonin
Primary outcome measure
1. Actigraphic sleep onset and offset and melatonin onset (defined as the time at which 4 pg/ml melatonin in saliva is reached)
2. Diary lights-off time
3. Sleep latency (latency between lights-off and sleep onset)
4. Sleep onset
5. Sleep duration
6. Sleep-offset and wake up time
7. Behaviour
8. Health status
Actigraphy data (for measurement of primary outcomes 1, 3, 4, 5 and 6) are collected during five days of week one, and five days of week two. Saliva collection (for the measurement of primary outcome 1) is done on day seven of week one and day seven of week two, for measurement of melatonin onset. The diary is recorded during all 14 days of the trial duration (for measurements of primary outcomes 2, 7, 8, and secondary outcome).
At this moment an interim analysis of the actigraphy results of week one (no medication) versus week two (with double blind placebo controlled medication) is ongoing, after 75 patients enrolled.
Secondary outcome measures
Possible side effects and adverse events will be evaluated.
Overall trial start date
01/05/2004
Overall trial end date
01/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. At inclusion physical examination, medial history and inclusion/exclusion assessments will be performed. The results of a hypnogram, performed within the past two months, showing a normal sleep architecture has to be known at inclusion
2. The children and their parents have to be motivated to comply the study protocol
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Child-psychiatric or family problems who can explain the sleep onset insomnia
2. Disturbed sleep architecture (hypnogram)
3. Use of Monoamine Oxidase (MAO) inhibitors
4. Children with known disturbed hepatic or renal function
5. Patients with the Roter syndrome
6. Patients with the Dubin-Johnson syndrome
7. Factors or diseases which can, according to the investigator, inhibit participation to the study
8. Medical, environmental, psychiatric or other factors, which can cause sleep onset insomnia during the trial
9. Participation in a study on the efficacy of drugs in the month preceding the inclusion
10. Mental retardation (Intelligence Quotient [IQ] less than 80)
11. Any prior use of melatonin
12. Use of hypnotics, antidepressants or neuroleptics
13. Chronic pain
14. Severe neurological or psychiatric disorder
Recruitment start date
01/05/2004
Recruitment end date
01/05/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht (UMCU)
Ede
6716 RP
Netherlands
Funders
Funder type
Industry
Funder name
Pharma Nord Denmark (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20668840
Publication citations
-
Results
van Geijlswijk IM, van der Heijden KB, Egberts AC, Korzilius HP, Smits MG, Dose finding of melatonin for chronic idiopathic childhood sleep onset insomnia: an RCT., Psychopharmacology (Berl.), 2010, 212, 3, 379-391, doi: 10.1007/s00213-010-1962-0.