drugset / Trial / NCT01393574

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

NCT01393574

Phase 4 Unknown 46 enrolled Assaf-Harofeh Medical Center
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-06
Primary completion
2012-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 3 mg
Subject Melatonin Small molecule 6 mg
Comparator Methylphenidate Small molecule