- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04318067
Melatonin in ADHD and Sleep Problems (MELAS)
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Allan Hvolby, MD, Ph.D
- Phone Number: 0045 99447300
- Email: allan.hvolby@rsyd.dk
Study Locations
-
-
-
Esbjerg, Denmark, 6715
- Recruiting
- Child and Adolescent Psychiatric department
-
Contact:
- Allan Hvolby, M.D., Ph.D
- Email: allan.hvolby@rsyd.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Allan Hvolby, MD, Ph.D, Child and adolescent Psychiatric department, South Jutland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Disease
- Sleep Wake Disorders
- Dyssomnias
- Parasomnias
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Protective Agents
- Antioxidants
- Melatonin
Other Study ID Numbers
- 18081070
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Sleep Disorder
-
Matrouh UniversitySuez Canal University; Beni-Suef University; University of Bisha, Saudia ArabiaCompletedSleep Disorder | Sleep Hygiene | Sleep Disorder; Insomnia Type | Sleep Disorder in Elderly | Sleep Disorder, Mental Health | Sleep Disorders, Physical HealthEgypt
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedSleep Disorder | Diarrhea | Anxiety Disorders | Insomnia | Sleep Initiation and Maintenance Disorders | Anxiety | Sleep Disturbance | Gastrointestinal Dysfunction | Heartburn | Caffeine | Caffeine Withdrawal | Caffeine; Sleep Disorder | Caffeine Dependence | Caffeine-Induced Anxiety Disorder | Caffeine-Induced Sleep... and other conditionsUnited States
-
Johannes Gutenberg University MainzRecruitingSleep Disorder | Restless Legs Syndrome | Insomnia | Sleep Apnea | Narcolepsy | Idiopathic Hypersomnia | Somnambulism | Sleep Disorder Parasomnia | REM Behavior DisorderGermany
-
Yale UniversityEnrolling by invitationCircadian Rhythm Sleep Disorder, UnspecifiedUnited States
-
The University of Texas Health Science Center,...Active, not recruitingRapid Eye Movement Sleep Behavior DisorderUnited States
-
Merck Sharp & Dohme LLCCompletedDyssomnias | Sleep Disorders | Mental Disorder | Sleep Initiation and Maintenance Disorder; Elderly | Sleep Disorder, Intrinsic
-
Vanda PharmaceuticalsRecruitingSleep Disorder | Sleep Disturbance | Autism Spectrum Disorder | Neurological DisorderUnited States
-
Assistance Publique Hopitaux De MarseilleAix Marseille UniversitéRecruitingREM Sleep Behaviour DisorderFrance
-
Yale UniversityNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingCritical Illness | Sleep Deprivation | Circadian Rhythm Sleep Disorder, UnspecifiedUnited States
-
Federal University of Minas GeraisHarvard Medical School (HMS and HSDM)Active, not recruitingDepressive Disorder | Quality of Life | Sleep Disorder | Anxiety Disorders | Insomnia | Spirituality | Stress Disorder | Insomnia Chronic | Insomnia Disorder | Complementary TherapyBrazil
Clinical Trials on Melatonin 3 mg
-
Providence Health & ServicesCompletedRelapsing Remitting Multiple SclerosisUnited States
-
UnivatesAline Patrícia Brietzke; Ana Paula CostellaRecruitingPerimenopausal DisorderBrazil
-
Northwell HealthColumbia University; National Library of Medicine (NLM)Completed
-
Chinese PLA General HospitalUnknown
-
Ain Shams UniversityCompletedCerebral Palsy | Growth | Children, Only | MelatoninEgypt
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
University of MilanCompletedMechanically Ventilated Patients | Critically Ill PatientsItaly
-
Universidad de MurciaUnknownSleep Disorders, Circadian RhythmSpain
-
Fayoum UniversityCompletedImpacted Third Molar ToothEgypt
-
Dana-Farber Cancer InstituteCompleted