Melatonin in ADHD and Sleep Problems (MELAS)
Primary Purpose
Attention Deficit Hyperactivity Disorder, Sleep Disorder
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Melatonin 3 mg
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Melatonin, Attention Deficit Hyperactivity Disorder, Sleep problems, Dim Light Melatonin Onset
Eligibility Criteria
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
Sites / Locations
- Child and Adolescent Psychiatric departmentRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sleep problems i Attention Deficit Hyperactivity Disorder
Arm Description
Children age 6 to 12 years having ADHD and Sleeping problem will be treated with Melatonin 3 mg one a day (before bedtime)
Outcomes
Primary Outcome Measures
Sleep onset Latency (SOL)
How long time does the child use falling asleep after lights out
Sleep onset
Time where child falls asleep
Total Sleep time
Secondary Outcome Measures
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.
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
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
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
Full Information
NCT ID
NCT04318067
First Posted
February 14, 2020
Last Updated
May 6, 2022
Sponsor
Allan Hvolby
Collaborators
Sygehus Lillebaelt
1. Study Identification
Unique Protocol Identification Number
NCT04318067
Brief Title
Melatonin in ADHD and Sleep Problems
Acronym
MELAS
Official Title
Melatonin - Production and Release in Children and Adolescents With ADHD and Chronic Sleep Problems and Effects of Melatonin on Sleep
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Allan Hvolby
Collaborators
Sygehus Lillebaelt
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Sleep Disorder
Keywords
Melatonin, Attention Deficit Hyperactivity Disorder, Sleep problems, Dim Light Melatonin Onset
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleep problems i Attention Deficit Hyperactivity Disorder
Arm Type
Experimental
Arm Description
Children age 6 to 12 years having ADHD and Sleeping problem will be treated with Melatonin 3 mg one a day (before bedtime)
Intervention Type
Drug
Intervention Name(s)
Melatonin 3 mg
Intervention Description
Melatonin 3 mg is given ones a day - at bedtimes for 6 month
Primary Outcome Measure Information:
Title
Sleep onset Latency (SOL)
Description
How long time does the child use falling asleep after lights out
Time Frame
6 month
Title
Sleep onset
Description
Time where child falls asleep
Time Frame
6 month
Title
Total Sleep time
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Attention Deficit Hyperactivity Disorder - Scale Score (ADHD-RS)
Description
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.
Time Frame
6 month
Title
Weiss Functional Impairment Rating Scale (WFIRS)
Description
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
Time Frame
6 month
Title
Dundee Difficult Times of the Day Scale (D-DTODS)
Description
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
Time Frame
6 month
Title
Side effect Rating Scale
Description
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
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allan Hvolby, MD, Ph.D
Phone
0045 99447300
Email
allan.hvolby@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Hvolby, MD, Ph.D
Organizational Affiliation
Child and adolescent Psychiatric department, South Jutland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Psychiatric department
City
Esbjerg
ZIP/Postal Code
6715
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan Hvolby, M.D., Ph.D
Email
allan.hvolby@rsyd.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Melatonin in ADHD and Sleep Problems
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