Melatonin in ADHD and Sleep Problems (MELAS)

May 6, 2022 updated by: Allan Hvolby

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Esbjerg, Denmark, 6715
        • Recruiting
        • Child and Adolescent Psychiatric department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Melatonin 3 mg is given ones a day - at bedtimes for 6 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep onset Latency (SOL)
Time Frame: 6 month
How long time does the child use falling asleep after lights out
6 month
Sleep onset
Time Frame: 6 month
Time where child falls asleep
6 month
Total Sleep time
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attention Deficit Hyperactivity Disorder - Scale Score (ADHD-RS)
Time Frame: 6 month
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
Weiss Functional Impairment Rating Scale (WFIRS)
Time Frame: 6 month
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
Dundee Difficult Times of the Day Scale (D-DTODS)
Time Frame: 6 month
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
Side effect Rating Scale
Time Frame: 6 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Allan Hvolby, MD, Ph.D, Child and adolescent Psychiatric department, South Jutland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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