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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Assaf-Harofeh Medical Center Identifier:
First received: July 12, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Sleep Onset Insomnia
Drug: Melatonin
Drug: Methylphenidate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 46
Study Start Date: June 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01393574

Contact: Amir Ytzhak, Dr. 972-8-9779944
Contact: Amir Livne, Dr. 972-8-9779944

Assaf Haroffeh Medical Center Recruiting
Zeriffin, Israel
Principal Investigator: Amir Ytzhak, Dr.         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

Responsible Party: principal investigator: Dr. Amir Ytzhak, Assaf-Harofeh Medical Center Identifier: NCT01393574     History of Changes
Other Study ID Numbers: 83/11
Study First Received: July 12, 2011
Last Updated: July 12, 2011

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Protective Agents
Central Nervous System Depressants processed this record on May 25, 2017