Melatonin in ADHD and Sleep Problems

Attention Deficit Hyperactivity Disorder Clinical Trial

— MELAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04318067
• Other study ID #: 18081070
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: November 2024

Study information

• Verified date: May 2022
• Source: Region of Southern Denmark
• Contact: Allan Hvolby, MD, Ph.D
• Phone: 0045 99447300
• Email: allan.hvolby[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Dyssomnias
• Hyperkinesis
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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

Locations

Country	Name	City	State
Denmark	Child and Adolescent Psychiatric department	Esbjerg

Sponsors (2)

Lead Sponsor	Collaborator
Allan Hvolby	Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep onset Latency (SOL)	How long time does the child use falling asleep after lights out	6 month
Primary	Sleep onset	Time where child falls asleep	6 month
Primary	Total Sleep time		6 month
Secondary	Attention Deficit Hyperactivity Disorder - Scale Score (ADHD-RS)	A Scale Score measuring ADHD symptoms on a 4 point Likert Scale (0-3) . 18 Question with a Total max score of 54, Total minimum Score is 0 . Higher score is more symptoms.	6 month
Secondary	Weiss Functional Impairment Rating Scale (WFIRS)	Evaluation on different Quality of Life (QoL) scores. 50 Question Measuring QoL in School, Family setting and Social activities on a 4 Point Likert Scale (0-3) with af total max score om 150 (minimum 0) - A higher score is more difficulties and lower Quality of Life	6 month
Secondary	Dundee Difficult Times of the Day Scale (D-DTODS)	On a 4 point Likert scale (1-4) the instrument asses the impact on Child and Family Self-Esteem and Quality of Life . Total max is 40 points and indicates low QoL and Minimum score is 10 and indicate Normal functioning and High QoL	6 month
Secondary	Side effect Rating Scale	Registration of 17 known possible Side Effekts on a Likert Scale 0-9 point each, With a total score of 153 points which indicate many and serious Side effect and a minimum of 0 , which indicate Zero side effects	6 month