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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01393574
• Other study ID #: 83/11
• Status: Recruiting
• Phase: Phase 4
• First received: July 12, 2011
• Last updated: July 12, 2011
• Start date: June 2011

Study information

• Verified date: July 2011
• Source: Assaf-Harofeh Medical Center
• Contact: Amir Ytzhak, Dr.
• Phone: 972-8-9779944
• Email: omnebene[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis
• Sleep Onset Insomnia

Intervention

Drug:
• Melatonin
3 mg for body weight <40kg, 6 mg for body weight >40kg, once a day 30-60 minutes before sleep
• 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)

Locations

Country	Name	City	State
Israel	Assaf Haroffeh Medical Center	Zeriffin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD symptoms improvement	ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report	a month	No
Secondary	Sleep difficulties improvement	Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary.	1 month	No