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

July 12, 2011 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zeriffin, Israel
        • Recruiting
        • Assaf Haroffeh Medical Center
        • Principal Investigator:
          • Amir Ytzhak, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Concerta
  • Ritalin
  • Ritalin LA
  • Ritalin SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
a month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Estimate)

July 13, 2011

Last Update Submitted That Met QC Criteria

July 12, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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