Back to resultsComparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
Primary Purpose
Attention Deficit Hyperactivity Disorder, Sleep Onset Insomnia
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Melatonin
Methylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility 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
Sites / Locations
- Assaf Haroffeh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Melatonin treatment
Stimulants treatment
Arm Description
Treatment with Melatonin before sleep for 1 month - 3 mg for body weight <40kg, 6mg for body weight >40kg
Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month.
Outcomes
Primary Outcome Measures
ADHD symptoms improvement
ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report
Secondary Outcome Measures
Sleep difficulties improvement
Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary.
Full Information
NCT ID
NCT01393574
First Posted
July 12, 2011
Last Updated
July 12, 2011
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01393574
Brief Title
Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
Official Title
Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Sleep Onset Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin treatment
Arm Type
Experimental
Arm Description
Treatment with Melatonin before sleep for 1 month - 3 mg for body weight <40kg, 6mg for body weight >40kg
Arm Title
Stimulants treatment
Arm Type
Active Comparator
Arm Description
Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month.
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
3 mg for body weight <40kg, 6 mg for body weight >40kg, once a day 30-60 minutes before sleep
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Ritalin, Ritalin SR, Ritalin LA, Concerta
Intervention Description
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)
Primary Outcome Measure Information:
Title
ADHD symptoms improvement
Description
ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report
Time Frame
a month
Secondary Outcome Measure Information:
Title
Sleep difficulties improvement
Description
Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Ytzhak, Dr.
Phone
972-8-9779944
Email
omnebene@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Livne, Dr.
Phone
972-8-9779944
Email
livnea@asaf.health.gov.il
Facility Information:
Facility Name
Assaf Haroffeh Medical Center
City
Zeriffin
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Ytzhak, Dr.
12. IPD Sharing Statement
Learn more about this trial
Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
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