NCT01393574

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Attention Deficit Hyperactivity Disorder
• Sleep Onset Insomnia

Interventions

Type	Name	Description
DRUG	Melatonin	3 mg for body weight \<40kg, 6 mg for body weight \>40kg, once a day 30-60 minutes before sleep
DRUG	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)

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• First posted: 2011-07-13
• Last updated: 2011-07-13

Locations

1 site across 1 country: Israel