Melatonin in ADHD and Sleep Problems (MELAS)

Allan Hvolby

Status and phase: Enrolling; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder; Sleep Disorder

Treatments: Drug: Melatonin 3 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04318067

18081070

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Sleep problems i Attention Deficit Hyperactivity Disorder

Experimental group

Description:

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

Treatment:

Drug: Melatonin 3 mg