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Melatonin in ADHD and Sleep Problems

NCT04318067 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-05-09

No results posted yet for this study

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.

Conditions

  • Attention Deficit Hyperactivity Disorder
  • Sleep Disorder

Interventions

DRUG

Melatonin 3 mg

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

Sponsors & Collaborators

  • Sygehus Lillebaelt

    collaborator OTHER

  • Allan Hvolby

    lead OTHER

Principal Investigators

  • Allan Hvolby, MD, Ph.D · Child and adolescent Psychiatric department, South Jutland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-04-30
Completion
2024-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04318067 on ClinicalTrials.gov