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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin treatment | Experimental | Treatment with Melatonin before sleep for 1 month - 3 mg for body weight <40kg, 6mg for body weight >40kg |
|
| Stimulants treatment | Active Comparator | Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 3 mg for body weight <40kg, 6 mg for body weight >40kg, once a day 30-60 minutes before sleep |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADHD symptoms improvement | ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report | a month |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep difficulties improvement | Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir Ytzhak, Dr. | Contact | 972-8-9779944 | omnebene@gmail.com | |
| Amir Livne, Dr. | Contact | 972-8-9779944 | livnea@asaf.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Haroffeh Medical Center | Recruiting | Zeriffin | Israel |
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| Methylphenidate | Drug | 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) |
|
|
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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