Trial | NCT04318067  Report issue

Title

Melatonin in ADHD and Sleep Problems
Melatonin - Production and Release in Children and Adolescents With ADHD and Chronic Sleep Problems and Effects of Melatonin on Sleep

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    80
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.
Study Started
Sep 01
2020
Primary Completion
Apr 30
2024
Anticipated
Study Completion
Nov 30
2024
Anticipated
Last Update
May 09
2022

Drug Melatonin 3 mg

Melatonin 3 mg is given ones a day - at bedtimes for 6 month

Sleep problems i Attention Deficit Hyperactivity Disorder Experimental

Children age 6 to 12 years having ADHD and Sleeping problem will be treated with Melatonin 3 mg one a day (before bedtime)

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
No Results Posted