A Dose-Ranging Study of a Methylphenidate Transdermal System in Children With ADHD
| Autor: | Brian T. Wymbs, Michael J. Manos, Donald A. Caserta, Elizabeth M. Gnagy, Andy Lopez-Williams, Lisa Burrows-MacLean, Gene D. Morse, Martin T. Hoffman, Katy E. Tresco, Gregory A. Fabiano, Cora E. Ezzell, Andrea M. Chronis, William E. Pelham, Adia N. Onyango |
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| Rok vydání: | 2005 |
| Předmět: |
Male
medicine.medical_specialty Administration Cutaneous Placebo law.invention Efficacy Double-Blind Method Randomized controlled trial law Developmental and Educational Psychology medicine Humans Attention deficit hyperactivity disorder Child Completely randomized design Morning Dose-Response Relationship Drug Methylphenidate medicine.disease Dose-ranging study Surgery Psychiatry and Mental health Treatment Outcome Attention Deficit Disorder with Hyperactivity Anesthesia Central Nervous System Stimulants Female Psychology medicine.drug |
| Zdroj: | Journal of the American Academy of Child & Adolescent Psychiatry. 44:522-529 |
| ISSN: | 0890-8567 |
| Popis: | Objective This was a multicenter, double-blind, randomized, dose-ranging study of a methylphenidate (MPH) transdermal system (MTS). Medication (placebo, 0.45, 0.9, and 1.8 mg/h) was crossed with application time (6 a.m., 7 a.m.) to evaluate MTS efficacy and influence of exposure time on morning effects. Method The study took place in a summer treatment program (STP) at three sites, with 36 children aged 7-12 years with attention-deficit/hyperactivity disorder. Each treatment was administered for 1 day in random order, for a total of 8 days. Behavioral and academic measures were taken as well as patch wear characteristics and side effects. Results Evaluable participant data were analyzed in a series of dose × application time multivariate analyses of variance. All MTS conditions were significantly different from placebo across measures. Time of application had no significant effect on daily behavior, and effects of application time on morning behavior were inconclusive. Consistent with previous results in this setting, the highest dose produced limited incremental benefit compared with the mid-range dose. The wear characteristics of the MTS were acceptable, and the formulation was well tolerated. Conclusions The MTS produced significant effects that were similar to those previously reported with comparable MPH doses. There does not appear to be a substantial effect of application time on total daily functioning in this setting; further controlled time-course studies will be necessary to evaluate the question of morning onset fully. |
| Databáze: | OpenAIRE |
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