Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
Recruitment status was: Recruiting
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.
|Attention Deficit Hyperactivity Disorder Sleep Onset Insomnia||Drug: Melatonin Drug: Methylphenidate||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties|
- ADHD symptoms improvement [ Time Frame: a month ]ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report
- Sleep difficulties improvement [ Time Frame: 1 month ]Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary.
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Melatonin treatment
Treatment with Melatonin before sleep for 1 month - 3 mg for body weight <40kg, 6mg for body weight >40kg
3 mg for body weight <40kg, 6 mg for body weight >40kg, once a day 30-60 minutes before sleep
Active Comparator: Stimulants treatment
Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month.
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393574
|Contact: Amir Ytzhak, Dr.||firstname.lastname@example.org|
|Contact: Amir Livne, Dr.||email@example.com|
|Assaf Haroffeh Medical Center||Recruiting|
|Principal Investigator: Amir Ytzhak, Dr.|