Attention Deficit Hyperactivity DisorderPhase 4MELASNCT04318067
Melatonin in ADHD and Sleep Problems
A Phase 4 study testing Melatonin 3 mg in people with Attention Deficit Hyperactivity Disorder and Sleep Disorder, run by Allan Hvolby at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Sleep Disorder
- What is being tested?
- Melatonin 3 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- IQ below 70
- Autism Disorder
- Actual or former treated with Melatonin
- Allergy to melatonin
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Child and Adolescent Psychiatric department
Esbjerg, 6715
Allan Hvolby, M.D., Ph.D, allan.hvolby@rsyd.dk
About this study
Official title: 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.
Read more
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.
- Being tested
- Melatonin 3 mg
- Keywords
- Melatonin, Attention Deficit Hyperactivity Disorder, Sleep problems, Dim Light Melatonin Onset
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Sleep Wake Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 mgDrug
Melatonin 3 mg is given ones a day - at bedtimes for 6 month
| Study group | Role | What they receive |
|---|---|---|
| Sleep problems i Attention Deficit Hyperactivity Disorder | Experimental | Children age 6 to 12 years having ADHD and Sleeping problem will be treated with Melatonin 3 mg one a day (before bedtime) Receives: Drug: Melatonin 3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep onset Latency (SOL)
How long time does the child use falling asleep after lights out
Measured: 6 month
Sleep onset
Time where child falls asleep
Measured: 6 month
Total Sleep time
Measured: 6 month
Secondary outcomes (4)
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.
Measured: 6 month
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
Measured: 6 month
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
Measured: 6 month
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Sep 2020
- Primary completionApr 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allan Hvolby
- Sponsor type
- University, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Responsible party
- Sponsor-investigator, Allan Hvolby, Region of Southern Denmark
- Investigators
- Allan Hvolby, MD, Ph.D, Principal investigator, Child and adolescent Psychiatric department, South Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318067
- Sponsor's protocol ID
- 18081070
- Acronym
- MELAS
- Status last verified
- May 2022
- First submitted
- 14 Feb 2020
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin - Production and Release in Children and Adolescents With ADHD and Chronic Sleep Problems and Effects of Melatonin on Sleep
- ClinicalTrials.gov ID
- NCT04318067
- Acronym / sponsor ID
- MELAS / 18081070
- Keywords
- Melatonin, Attention Deficit Hyperactivity Disorder, Sleep problems, Dim Light Melatonin Onset
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Allan HvolbyUniversity, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep problems i Attention Deficit Hyperactivity Disorder | Experimental | Drug: Melatonin 3 mgChildren age 6 to 12 years having ADHD and Sleeping problem will be treated with Melatonin 3 mg one a day (before bedtime) |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- IQ below 70
- Autism Disorder
- Actual or former treated with Melatonin
- Allergy to melatonin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 3 mgMelatonin 3 mg is given ones a day - at bedtimes for 6 month | Drug | Sleep problems i Attention Deficit Hyperactivity Disorder |
Primary outcome
Sleep onset Latency (SOL)
Time frame: 6 month
How long time does the child use falling asleep after lights out
Sleep onset
Time frame: 6 month
Time where child falls asleep
Total Sleep time
Time frame: 6 month
4 secondary outcomes
Attention Deficit Hyperactivity Disorder - Scale Score (ADHD-RS)
Time frame: 6 month
Weiss Functional Impairment Rating Scale (WFIRS)
Time frame: 6 month
Dundee Difficult Times of the Day Scale (D-DTODS)
Time frame: 6 month
Side effect Rating Scale
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Hvolby, MD, Ph.D principal investigator
Child and adolescent Psychiatric department, South Jutland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin 3 mg in people with Attention Deficit Hyperactivity Disorder and Sleep Disorder, run by Allan Hvolby at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan Hvolby, MD, Ph.D (0045 99447300, allan.hvolby@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep onset Latency (SOL) (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.