Initiating Concerta(TM) (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder

J. Swanson, L. Greenhill, W. Pelham, T. Wilens, M. Wolraich, H. Abikoff, M. Atkins, G. August, J. Biederman, O. Bukstein, C. K. Conners, L. Efron, K. Fiebelkorn, J. Fried, M. Hoffman, L. Lambrecht, M. Lerner, B. Leventhal, K. McBurnett, E. MorseD. Palumbo, L. Pfiffner, M. Stein, S. Wigal, E. Winans

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

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 languageEnglish (US)
Pages (from-to)59-76
Number of pages18
JournalJournal of Clinical Research
Volume3
Issue number59-76
StatePublished - Sep 14 2000

Fingerprint

Methylphenidate
Attention Deficit Disorder with Hyperactivity
Therapeutics
Research Personnel
Symptom Assessment
Caregivers
Parents
Safety

Keywords

  • ADHD
  • Attention-deficit hyperactivity disorder
  • Concerta(TM)
  • Methylphenidate
  • OROS®

Cite this

Swanson, J., Greenhill, L., Pelham, W., Wilens, T., Wolraich, M., Abikoff, H., ... Winans, E. (2000). Initiating Concerta(TM) (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder. Journal of Clinical Research, 3(59-76), 59-76.

Initiating Concerta(TM) (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder. / Swanson, J.; Greenhill, L.; Pelham, W.; Wilens, T.; Wolraich, M.; Abikoff, H.; Atkins, M.; August, G.; Biederman, J.; Bukstein, O.; Conners, C. K.; Efron, L.; Fiebelkorn, K.; Fried, J.; Hoffman, M.; Lambrecht, L.; Lerner, M.; Leventhal, B.; McBurnett, K.; Morse, E.; Palumbo, D.; Pfiffner, L.; Stein, M.; Wigal, S.; Winans, E.

In: Journal of Clinical Research, Vol. 3, No. 59-76, 14.09.2000, p. 59-76.

Research output: Contribution to journalArticle

Swanson, J, Greenhill, L, Pelham, W, Wilens, T, Wolraich, M, Abikoff, H, Atkins, M, August, G, Biederman, J, Bukstein, O, Conners, CK, Efron, L, Fiebelkorn, K, Fried, J, Hoffman, M, Lambrecht, L, Lerner, M, Leventhal, B, McBurnett, K, Morse, E, Palumbo, D, Pfiffner, L, Stein, M, Wigal, S & Winans, E 2000, 'Initiating Concerta(TM) (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder', Journal of Clinical Research, vol. 3, no. 59-76, pp. 59-76.
Swanson J, Greenhill L, Pelham W, Wilens T, Wolraich M, Abikoff H et al. Initiating Concerta(TM) (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder. Journal of Clinical Research. 2000 Sep 14;3(59-76):59-76.
Swanson, J. ; Greenhill, L. ; Pelham, W. ; Wilens, T. ; Wolraich, M. ; Abikoff, H. ; Atkins, M. ; August, G. ; Biederman, J. ; Bukstein, O. ; Conners, C. K. ; Efron, L. ; Fiebelkorn, K. ; Fried, J. ; Hoffman, M. ; Lambrecht, L. ; Lerner, M. ; Leventhal, B. ; McBurnett, K. ; Morse, E. ; Palumbo, D. ; Pfiffner, L. ; Stein, M. ; Wigal, S. ; Winans, E. / Initiating Concerta(TM) (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder. In: Journal of Clinical Research. 2000 ; Vol. 3, No. 59-76. pp. 59-76.
@article{61f0ec6ba68046e491cae6f8b294186a,
title = "Initiating Concerta(TM) (OROS{\circledR} methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder",
abstract = "The objective of this study was to determine a tolerable method of initiating Concerta(TM) (OROS{\circledR} 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.",
keywords = "ADHD, Attention-deficit hyperactivity disorder, Concerta(TM), Methylphenidate, OROS{\circledR}",
author = "J. Swanson and L. Greenhill and W. Pelham and T. Wilens and M. Wolraich and H. Abikoff and M. Atkins and G. August and J. Biederman and O. Bukstein and Conners, {C. K.} and L. Efron and K. Fiebelkorn and J. Fried and M. Hoffman and L. Lambrecht and M. Lerner and B. Leventhal and K. McBurnett and E. Morse and D. Palumbo and L. Pfiffner and M. Stein and S. Wigal and E. Winans",
year = "2000",
month = "9",
day = "14",
language = "English (US)",
volume = "3",
pages = "59--76",
journal = "Journal of Clinical Research",
issn = "1369-5207",
publisher = "PJB Publications Ltd.",
number = "59-76",

}

TY - JOUR

T1 - Initiating Concerta(TM) (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder

AU - Swanson, J.

AU - Greenhill, L.

AU - Pelham, W.

AU - Wilens, T.

AU - Wolraich, M.

AU - Abikoff, H.

AU - Atkins, M.

AU - August, G.

AU - Biederman, J.

AU - Bukstein, O.

AU - Conners, C. K.

AU - Efron, L.

AU - Fiebelkorn, K.

AU - Fried, J.

AU - Hoffman, M.

AU - Lambrecht, L.

AU - Lerner, M.

AU - Leventhal, B.

AU - McBurnett, K.

AU - Morse, E.

AU - Palumbo, D.

AU - Pfiffner, L.

AU - Stein, M.

AU - Wigal, S.

AU - Winans, E.

PY - 2000/9/14

Y1 - 2000/9/14

N2 - 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.

AB - 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.

KW - ADHD

KW - Attention-deficit hyperactivity disorder

KW - Concerta(TM)

KW - Methylphenidate

KW - OROS®

UR - http://www.scopus.com/inward/record.url?scp=0033850239&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033850239&partnerID=8YFLogxK

M3 - Article

AN - SCOPUS:0033850239

VL - 3

SP - 59

EP - 76

JO - Journal of Clinical Research

JF - Journal of Clinical Research

SN - 1369-5207

IS - 59-76

ER -