Attention Deficit Hyperactivity DisorderPhase 4NCT01393574
Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
A Phase 4 study testing Melatonin and Methylphenidate in people with Attention Deficit Hyperactivity Disorder and Sleep Onset Insomnia, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Sleep Onset Insomnia
- What is being tested?
- Melatonin and Methylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Haroffeh Medical Center
Zeriffin
Amir Ytzhak, Dr.
About this study
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.
- Being tested
- Melatonin, Methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
3 mg for body weight <40kg, 6 mg for body weight >40kg, once a day 30-60 minutes before sleep
MethylphenidateDrug
Also called Ritalin, Ritalin SR, Ritalin LA, Concerta
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)
| Study group | Role | What they receive |
|---|---|---|
| Melatonin treatment | Experimental | Treatment with Melatonin before sleep for 1 month - 3 mg for body weight <40kg, 6mg for body weight >40kg Receives: Drug: Melatonin |
| Stimulants treatment | Active comparator | Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month. Receives: Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms improvement
ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report
Measured: a month
Secondary outcomes (1)
Sleep difficulties improvement
Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393574
- Sponsor's protocol ID
- 83/11
- Status last verified
- Jul 2011
- First submitted
- 12 Jul 2011
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
- ClinicalTrials.gov ID
- NCT01393574
- Acronym / sponsor ID
- 83/11
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (estimated)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin treatment | Experimental | Drug: MelatoninTreatment with Melatonin before sleep for 1 month - 3 mg for body weight <40kg, 6mg for body weight >40kg |
| Stimulants treatment | Active comparator | Drug: MethylphenidateTreatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin3 mg for body weight <40kg, 6 mg for body weight >40kg, once a day 30-60 minutes before sleep | Drug | Melatonin treatment |
| MethylphenidateAlso: Ritalin, Ritalin SR, Ritalin LA, ConcertaDrug 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) | Drug | Stimulants treatment |
Primary outcome
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
1 secondary outcome
Sleep difficulties improvement
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin and Methylphenidate in people with Attention Deficit Hyperactivity Disorder and Sleep Onset Insomnia, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Ytzhak, Dr. (972-8-9779944, omnebene@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD symptoms improvement (time frame: a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2011.