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

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ClinicalTrials.gov Identifier: NCT01393574
Recruitment Status : Unknown
Verified July 2011 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Sleep Onset Insomnia Drug: Melatonin Drug: Methylphenidate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
Study Start Date : June 2011
Estimated Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Melatonin treatment
Treatment with Melatonin before sleep for 1 month - 3 mg for body weight <40kg, 6mg for body weight >40kg
 Drug: Melatonin
3 mg for body weight <40kg, 6 mg for body weight >40kg, once a day 30-60 minutes before sleep
Active Comparator: Stimulants treatment
Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month.
 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)
Other Names:
  • Ritalin
  • Ritalin SR
  • Ritalin LA
  • Concerta


Outcome Measures
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Primary Outcome Measures :
  1. ADHD symptoms improvement [ Time Frame: a month ]
    ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report


Secondary Outcome Measures :
  1. Sleep difficulties improvement [ Time Frame: 1 month ]
    Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393574


Contacts
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Contact: Amir Ytzhak, Dr. 972-8-9779944 omnebene@gmail.com
Contact: Amir Livne, Dr. 972-8-9779944 livnea@asaf.health.gov.il

Locations
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Israel
Assaf Haroffeh Medical Center Recruiting
Zeriffin, Israel
Principal Investigator: Amir Ytzhak, Dr.         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information
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Responsible Party: principal investigator: Dr. Amir Ytzhak, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01393574    
Other Study ID Numbers: 83/11
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Nervous System Diseases
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
Melatonin
Methylphenidate
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Neurotransmitter Agents