Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
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|ClinicalTrials.gov Identifier: NCT01393574|
Recruitment Status : Unknown
Verified July 2011 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder Sleep Onset Insomnia||Drug: Melatonin Drug: Methylphenidate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||June 2012|
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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|