Efficacy and Safety of Oros Methylphenidate Hcl Compared with Immediate- Release Methylphenidate Hcl in Children with Adhd
Resource
43RD CONGRESS OF THE TAIWANESE PSYCHIATRIC SOCIETY, NOVEMBER 6 AND 7, 2004, CHENG-KONG UNIVERSITY, TAINAN, TAIWAN. v.43RD
Journal
43RD CONGRESS OF THE TAIWANESE PSYCHIATRIC SOCIETY
Journal Issue
NOVEMBER 6 AND 7
Pages
-
Date Issued
2004
Date
2004
Author(s)
GAU, SUSAN SHUR-FEN
SHENG, HSIN-YIH
SOONG, WEI-TSUEN
GAU, CHURN-SHIOUH
Abstract
Objectives: To evaluate the efficacy and safety of Concerta( extended- release methylphenidate, OROS MPH) as compared with Ritalin (Immediate- Release Methylphenidate HCL, IR MPH) among children with attention-deficit hyperactivity disorder(ADHD). Efficacy will be evaluated in the community setting by school teachers, parent/caregivers, and investigators using standardized attention and behavior scales and other assessments. Methods: This is an open, randomized, Ritalin- controlled, parallel group trial. Sample consisted of 64 patients with ADHD aged 6-15 recruited from Jan to March 2004. Patients were randomly assigned to one of the two treatments: (1) Treatment A ( Concerta) – 1 or 2 Concerta 18 mg tablets once daily at 07: 30 am, and (2)Treatment B ( Ritalin) – 0.5 or 1 tablets of Ritalin 10 mg at 07:30 am, 12:00 pm, and 4:00 pm for 28 days. On study day –1, 6, 13, 20, and 27, the patient’sbehavior and attention were assessed over each previous week of the study by the school teacher and parent using the Conner’s Teacher and Parent Rating Scale-Revised: Short Form (CTRS-R:S and CPRS-R:S). The SKAMP Rating Scale was taken on study day –1, 13 and 27 by the school teachers. Global assessments of treatment effects were determined by a parent and the investigator at the end of treatment. The patient’s appetite and sleep quality as well as other side effects were evaluated globally at baseline, and after 2 and 4 weeks of treatment using Barkley’s Side Effect Rating Scale. A mixed model and generalized linear model were used to conduct analysis of variance. was taken on study day –1, 13 and 27 by the school teachers. Global assessments of treatment effects were determined by a parent and the investigator at the end of treatment. The
Subjects
OROS MPH
IR MPH
attention-deficit hyperactivity disorder
randomized clinical trial
efficacy