Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
NCT ID: NCT01393574
Last Updated: 2011-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
46 participants
INTERVENTIONAL
2011-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Melatonin treatment
Treatment with Melatonin before sleep for 1 month - 3 mg for body weight \<40kg, 6mg for body weight \>40kg
Melatonin
3 mg for body weight \<40kg, 6 mg for body weight \>40kg, once a day 30-60 minutes before sleep
Stimulants treatment
Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month.
Methylphenidate
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)
Interventions
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Melatonin
3 mg for body weight \<40kg, 6 mg for body weight \>40kg, once a day 30-60 minutes before sleep
Methylphenidate
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Also they suffer from sleep onset insomnia or difficult awakening
Exclusion Criteria
* Any other chronic medical treatment
* Sleep disorder requiring a different treatment
* Asthma in the last 2 years
6 Years
18 Years
ALL
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Assaf-Harofeh Medical Center
Locations
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Assaf Haroffeh Medical Center
Zeriffin, , Israel
Countries
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Central Contacts
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Other Identifiers
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83/11
Identifier Type: -
Identifier Source: org_study_id
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