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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assaf-Harofeh Medical Center
• Treatments: Central Nervous System Stimulants; Melatonin; Methylphenidate

Criteria

Inclusion Criteria:

• children 6-18 years old with a new ADHD diagnosis who are candidates for treatment with stimulants

• Also they suffer from sleep onset insomnia or difficult awakening

Exclusion Criteria:

• Drug treatment for ADHD or for sleep problems in the last 6 months

• Any other chronic medical treatment

• Sleep disorder requiring a different treatment

• Asthma in the last 2 years