Condition category
Mental and Behavioural Disorders
Date applied
13/04/2007
Date assigned
13/04/2007
Last edited
08/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.medsys/meldos.nl

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 measures

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

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

Sponsor information

Organisation

Hospital Pharmacy of the Valley of Gelderland (Ziekenhuisapotheek Gelderse Vallei) (The Netherlands)

Sponsor details

Willy Brandtlaan 10
Ede
6716 RP
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20668840

Publication citations

  1. 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.

Additional files

Editorial Notes