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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
3 mg for body weight \<40kg, 6 mg for body weight \>40kg, once a day 30-60 minutes before sleep
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)
Assaf Haroffeh Medical Center
Zeriffin, Israel
RECRUITINGADHD symptoms improvement
ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report
Time frame: a month
Sleep difficulties improvement
Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary.
Time frame: 1 month
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