Clinical trial NCT04318067: Melatonin in ADHD and Sleep Problems
Official title: Melatonin - Production and Release in Children and Adolescents With ADHD and Chronic Sleep Problems and Effects of Melatonin on Sleep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Sleep Disorder
Keywords: Melatonin
Attention Deficit Hyperactivity Disorder
Sleep problems
Dim Light Melatonin Onset
Lead sponsor: Region of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Sygehus Lillebaelt
First posted: 2020-03-23
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment with melatonin is often initiated on an insufficient basis as it has not been established prior to starting the treatment whether or not the child had delayed release of endogenous melatonin. At the clinic, it has furthermore been observed that the length of time a child experiences an effect of melatonin treatment varies substantially.

In a clinical context, treatment with melatonin is used increasingly (www.Medstat.dk). However, there is no tradition in Denmark for measuring the endogenous melatonin level before initiating such treatment. Hence there is no way of knowing to what extent the sleep problems were indeed caused by delayed melatonin release.

There seem to be no studies on the difference in the effect of melatonin treatment of children and adolescents depending on whether or not they have delayed DLMO. Likewise, there are no studies including adolescents.

As can be seen, it is important to gain more knowledge about the normal release of melatonin, and the release of melatonin in a group of children and adolescents with a variety of psychiatric diagnoses. It is also essential to investigate whether there are any differences in the release of melatonin in children and adolescents with chronic sleep onset problem and children and adolescents who do not have sleep problems.


Eligibility criteria: Inclusion Criteria:

* Children aged 6-13 years referred to the child and adolescent psychiatric department for examination/treatment for ADHD
* Verified Cronical Sleep Problems
* Measured Dim Light Melatonin Onset

Exclusion Criteria:

* IQ below 70
* Autism Disorder
* Actual or former treated with Melatonin
* Allergy to melatonin

Primary outcomes:
measure: Sleep onset Latency (SOL)
timeFrame: 6 month
measure: Sleep onset
timeFrame: 6 month
measure: Total Sleep time
timeFrame: 6 month
Secondary outcomes:
measure: Attention Deficit Hyperactivity Disorder - Scale Score (ADHD-RS)
timeFrame: 6 month
measure: Weiss Functional Impairment Rating Scale (WFIRS)
timeFrame: 6 month
measure: Dundee Difficult Times of the Day Scale (D-DTODS)
timeFrame: 6 month
measure: Side effect Rating Scale
timeFrame: 6 month
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Child and Adolescent Psychiatric department
Study officials:
affiliation: Child and adolescent Psychiatric department, South Jutland
name: Allan Hvolby, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: