Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties

Study Overview
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Brief Summary
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The study hypothesis is that some children with Attention-Deficit-Hyperactivity-Disorder (ADHD) who also have sleep onset difficulties will improve with Melatonin treatment to an extent similar to that of stimulants treatment. In order to check this hypothesis children with a new ADHD diagnosis who also have sleep difficulties will be treated with either Melatonin or with stimulants (Methylphenidate) for one month. The main outcome will be improvement of the ADHD symptoms.

Official Title
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Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties

Conditions
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Attention Deficit Hyperactivity Disorder, Sleep Onset Insomnia

Intervention / Treatment
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* Drug: Melatonin
* Drug: Methylphenidate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children 6-18 years old with a new ADHD diagnosis who are candidates for treatment with stimulants Also they suffer from sleep onset insomnia or difficult awakening Exclusion Criteria: Drug treatment for ADHD or for sleep problems in the last 6 months Any other chronic medical treatment Sleep disorder requiring a different treatment Asthma in the last 2 years

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin treatment<br>Treatment with Melatonin before sleep for 1 month - 3 mg for body weight <40kg, 6mg for body weight >40kg | Drug: Melatonin<br>* 3 mg for body weight <40kg, 6 mg for body weight >40kg, once a day 30-60 minutes before sleep<br>|
| Active Comparator: Stimulants treatment<br>Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month. | Drug: Methylphenidate<br>* Drug formulary and dose will be decided by the treating neurologist from the available options in Israel (as would be given if not participating in the trial)<br>* Other names: Concerta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD symptoms improvement | ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report | a month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep difficulties improvement | Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary. | 1 month |