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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS methylphenidate and placebo. Each week, parent report measures, clinical interviews, and safety assessments are conducted.
Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype will predict response
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | OROS methylphenidate 18, 36, 54m placebo in randomized order (except never starting with highest dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OROS methylphenidate | Drug | 18, 36, 54 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| ADHD RS | weekly |
| Measure | Description | Time Frame |
|---|---|---|
| CGI-S | weekly | |
| VItal Signs | weekly | |
| Sleep Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Stein, Ph.D. | Univesity of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HALP Clinic, University of Illinois at CHicago | Chicago | Illinois | 60608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14595084 | Result | Stein MA, Sarampote CS, Waldman ID, Robb AS, Conlon C, Pearl PL, Black DO, Seymour KE, Newcorn JH. A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics. 2003 Nov;112(5):e404. doi: 10.1542/peds.112.5.e404. | |
| 15827573 | Result | Stein MA, Waldman ID, Sarampote CS, Seymour KE, Robb AS, Conlon C, Kim SJ, Cook EH. Dopamine transporter genotype and methylphenidate dose response in children with ADHD. Neuropsychopharmacology. 2005 Jul;30(7):1374-82. doi: 10.1038/sj.npp.1300718. |
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| 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 |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| weekly |
| Side Effects rating Scale | weekly |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |