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 because the information has not been verified recently.
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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Stimulants
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on May 03, 2016