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 |
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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
Contact information
Dr I M van Geijlswijk
Scientific
Scientific
University Medical Center Utrecht (UMCU)
Pharmacy of Faculty Animal Medicine
Ede
6716 RP
Netherlands
Phone | +31 (0)30 253 2066 |
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i.m.vangeijlswijk@vet.uu.nl |
Study information
Study design | Randomised, placebo controlled, parallel group, double blinded trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Scientific title | |
Study acronym | MELDOS |
Study objectives | 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(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) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2004 |
Completion date | 01/05/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Sex | Both |
Target number of participants | 150 |
Key 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 |
Key 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 |
Date of first enrolment | 01/05/2004 |
Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht (UMCU)
Ede
6716 RP
Netherlands
6716 RP
Netherlands
Sponsor information
Hospital Pharmacy of the Valley of Gelderland (Ziekenhuisapotheek Gelderse Vallei) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Willy Brandtlaan 10
Ede
6716 RP
Netherlands
https://ror.org/03862t386 |
Funders
Funder type
Industry
Pharma Nord Denmark (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/10/2010 | Yes | No |