MELatonin for children with idiopathic chronic sleep onset insomnia, with or without attention deficit hyperkinesia disorder - a DOSe finding trial: a randomised placebo-controlled double-blind parallel group trial

ISRCTN ISRCTN20033346
DOI https://doi.org/10.1186/ISRCTN20033346
Secondary identifying numbers MELDOS VERSION 2.0
Submission date
13/04/2007
Registration date
13/04/2007
Last edited
08/11/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr I M van Geijlswijk
Scientific

University Medical Center Utrecht (UMCU)
Pharmacy of Faculty Animal Medicine
Ede
6716 RP
Netherlands

Phone +31 (0)30 253 2066
Email i.m.vangeijlswijk@vet.uu.nl

Study information

Study designRandomised, placebo controlled, parallel group, double blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study acronymMELDOS
Study objectivesChronic 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(s)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).
Health condition(s) or problem(s) studiedInsomnia, Attention Deficit Hyperactivity Disorder (ADHD), sleep disorders
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Melatonin
Primary outcome measure1. 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 measuresPossible side effects and adverse events will be evaluated.
Overall study start date01/05/2004
Completion date01/05/2007

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants150
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/05/2004
Date of final enrolment01/05/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Utrecht (UMCU)
Ede
6716 RP
Netherlands

Sponsor information

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

Willy Brandtlaan 10
Ede
6716 RP
Netherlands

ROR logo "ROR" https://ror.org/03862t386

Funders

Funder type

Industry

Pharma Nord Denmark (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2010 Yes No