drugset / Trial / NCT04318067

Melatonin in ADHD and Sleep Problems

NCT04318067

Phase 4 Unknown 80 enrolled Allan Hvolby Sygehus Lillebaelt · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-01
Primary completion
2024-04
Completion
2024-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 3 mg