drugset / Trial / NCT00663442
Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD)
Phase 4
Completed
48 enrolled
University of Illinois at Chicago
National Institute of Mental Health (NIMH) · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
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
Timeline
- Start
- 1999-12
- Primary completion
- 2004-11
- Completion
- 2004-11
Publications
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylphenidate | Small molecule | 18 mg | — |
| Subject | Methylphenidate | Small molecule | 36 mg | — |
| Subject | Methylphenidate | Small molecule | 54 mg | — |