A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Methylphenidate Transdermal System in Pediatric Patients With Attention-Deficit/Hyperactivity Disorder
| Autor: | Robert L. Findling, Frank A. Lopez, Raun D. Melmed, Floyd R. Sallee, L. Eugene Arnold, Raymond D. Pratt, Oscar G. Bukstein |
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| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Nausea Administration Cutaneous Placebo Severity of Illness Index law.invention Double-Blind Method Randomized controlled trial law medicine Humans Attention deficit hyperactivity disorder Child Psychiatry Adverse effect Transdermal Methylphenidate medicine.disease Diagnostic and Statistical Manual of Mental Disorders Psychiatry and Mental health Tolerability Attention Deficit Disorder with Hyperactivity Anesthesia Central Nervous System Stimulants Female medicine.symptom Psychology medicine.drug |
| Zdroj: | The Journal of Clinical Psychiatry. 69:149-159 |
| ISSN: | 0160-6689 |
| DOI: | 10.4088/jcp.v69n0120 |
| Popis: | OBJECTIVE To evaluate the efficacy and safety of methylphenidate transdermal system compared with placebo, using osmotic-release oral system (OROS) methylphenidate as a reference therapy. METHOD We conducted a 7-week, randomized, double-blind, double-dummy, placebo-controlled trial in children diagnosed with attention-deficit/hyperactivity disorder by DSM-IV-TR criteria, within a community setting. The study was conducted from August 2004 to February 2005. Participants were randomly assigned to 1 of 3 treatments: methylphenidate transdermal system patch plus placebo capsule (N = 100), OROS methylphenidate capsule plus placebo patch (N = 94), or placebo capsule plus placebo patch (N = 88). Over 5 weeks, once-daily doses were optimized using 10-, 15-, 20-, and 30-mg methylphenidate transdermal system patches (9-hour wear time) or 18-, 27-, 36-, and 54-mg OROS methylphenidate capsules. Thereafter, optimal treatment doses were maintained for 2 weeks with blinded ratings of attention, behavior, and academic performance occurring at the end of each week. The primary efficacy measure was the clinician-rated ADHD Rating Scale-Version IV (ADHD-RS-IV). Additional measures included teacher, parent, and other clinician rating scales. Safety and tolerability were assessed throughout the study. RESULTS The mean change from baseline in ADHD-RS-IV scores was greater for participants receiving methylphenidate transdermal system and OROS methylphenidate treatments compared with placebo (p < .0001). Similar results were observed for parent and teacher rating scales. More participants receiving active treatments compared with placebo were rated as improved by clinicians and parents (p < .0001). Adverse events were generally mild or moderate in intensity, and the most common included decreased appetite, nausea, vomiting, and insomnia. CONCLUSIONS The results of this study suggest that the methylphenidate transdermal system is an efficacious treatment option for children with attention-deficit/hyperactivity disorder. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00444574. |
| Databáze: | OpenAIRE |
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