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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- 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.
- 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318067
|Contact: Allan Hvolby, MD, Ph.D||0045 firstname.lastname@example.org|
|Principal Investigator:||Allan Hvolby, MD, Ph.D||Child and adolescent Psychiatric department, South Jutland|