The objective of this study was to determine a tolerable method of initiating Concerta(TM) (OROS® methylphenidate HCl) treatment in children with attention-deficit hyperactivity disorder (ADHD) not currently receiving methylphenidate (MPH) treatment. A group of 99 children with ADHD (all subtypes, ages 6-12 years old) were evaluated in an open-label, dose-ranging, 1- to 4-week stepwise titration trial. Patients were initiated on Concerta(TM) 18 mg given once-daily (qd), advancing to 36 mg qd and to 54 mg qd if they did not respond adequately to the previous dose. Each patient was treated at the lowest dose for 1 week and evaluated for tolerability and effectiveness. Patients proceeded to the subsequent higher dose only if the lower dose produced no unacceptable side effects and, in the investigator's opinion, there was potential clinical benefit at the higher dose. Initiation was successfully completed once patients received a tolerable and effective dose, as judged by the investigator, based on the weekly symptom and safety assessments by parents/caregivers and teachers. Clinicians judged that 95 patients (96.0%) were successfully dose titrated (final Concerta(TM) dose: 18 mg, n = 18; 36 mg, n = 52; 54 mg, n = 25). Of the unsuccessfully titrated patients, one found treatment ineffective at the maximum dose and four discontinued treatment prematurely. The data showed a marked improvement in patients' behavior and attention at the final treatment dose compared to baseline. Once-daily Concerta(TM) treatment, implemented using this open-label, stepwise, dose-titration protocol, was well tolerated in children with ADHD not currently receiving MPH treatment. Children were initiated tolerably and effectively on once-daily Concerta(TM) treatment without prior titration on immediate-release MPH.
|Original language||English (US)|
|Number of pages||18|
|Journal||Journal of Clinical Research|
|State||Published - Sep 14 2000|
- Attention-deficit hyperactivity disorder