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Melatonin in ADHD and Sleep Problems (MELAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318067
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
Sygehus Lillebaelt
Information provided by (Responsible Party):
Allan Hvolby, Region of Southern Denmark

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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Sleep Disorder Drug: Melatonin 3 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Melatonin - Production and Release in Children and Adolescents With ADHD and Chronic Sleep Problems and Effects of Melatonin on Sleep
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

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




Primary Outcome Measures :
  1. Sleep onset Latency (SOL) [ Time Frame: 6 month ]
    How long time does the child use falling asleep after lights out

  2. Sleep onset [ Time Frame: 6 month ]
    Time where child falls asleep

  3. Total Sleep time [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318067


Contacts
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Contact: Allan Hvolby, MD, Ph.D 0045 99447300 allan.hvolby@rsyd.dk

Sponsors and Collaborators
Allan Hvolby
Sygehus Lillebaelt
Investigators
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Principal Investigator: Allan Hvolby, MD, Ph.D Child and adolescent Psychiatric department, South Jutland
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Responsible Party: Allan Hvolby, Principal Investigator, MD, Ph.D, Region of Southern Denmark
ClinicalTrials.gov Identifier: NCT04318067    
Other Study ID Numbers: 18081070
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Allan Hvolby, Region of Southern Denmark:
Melatonin
Attention Deficit Hyperactivity Disorder
Sleep problems
Dim Light Melatonin Onset
Additional relevant MeSH terms:
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Hyperkinesis
Sleep Wake Disorders
Parasomnias
Dyssomnias
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants