Melatonin in ADHD and Sleep Problems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder Sleep Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sleep problems i Attention Deficit Hyperactivity Disorder

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

Group Type EXPERIMENTAL

Melatonin 3 mg

Intervention Type DRUG

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

Interventions

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Melatonin 3 mg

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

Intervention Type DRUG

Eligibility Criteria

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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