Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder

Timothy E. Wilens, Keith McBurnett, Oscar Bukstein, James McGough, Laurence Greenhill, Marc Lerner, Mark A. Stein, C. Keith Conners, John Duby, Jeffrey Newcorn, Charles E. Bailey, Christopher J Kratochvil, Daniel Coury, Charles Casat, Mary Joan C Denisco, Patricia Halstead, Leslie Bloom, Brenda A. Zimmerman, Joan Gu, Kimberly M. Cooper & 1 others Joseph M. Lynch

Research output: Contribution to journalArticle

116 Citations (Scopus)

Abstract

Background: Despite the persistence of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known about the efficacy and tolerability of stimulant medications in this age group. Objective: To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system (OROS) methylphenidate. Design: Adolescents (N=220) having a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria. Subjects successfully completing the dose titration phase (n=177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo. Treatment effectiveness was measured using investigator, parent, and adolescent assessments of ADHD. Results: A significant reduction from baseline in the investigator-rated ADHD Rating Scale, the primary efficacy measure, was found with OROS methylphenidate treatment compared with placebo. Similar findings were noted with parent- and adolescent-report measures. Based on a Clinical Global Impression improvement subscale score of much or very much improved, 52% of subjects in the OROS methylphenidate group improved compared with 31% receiving placebo. Thirty-seven percent of subjects required the maximum dosage of 72 mg/d. The incidence of drug-related adverse events was similar between the 2 study groups. Conclusion: In adolescents, once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d.

Original languageEnglish (US)
Pages (from-to)82-90
Number of pages9
JournalArchives of Pediatrics and Adolescent Medicine
Volume160
Issue number1
DOIs
StatePublished - Jan 1 2006

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Methylphenidate
Attention Deficit Disorder with Hyperactivity
Placebos
Therapeutics
Research Personnel
Drug-Related Side Effects and Adverse Reactions
Diagnostic and Statistical Manual of Mental Disorders
Age Groups
Incidence

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder. / Wilens, Timothy E.; McBurnett, Keith; Bukstein, Oscar; McGough, James; Greenhill, Laurence; Lerner, Marc; Stein, Mark A.; Conners, C. Keith; Duby, John; Newcorn, Jeffrey; Bailey, Charles E.; Kratochvil, Christopher J; Coury, Daniel; Casat, Charles; Denisco, Mary Joan C; Halstead, Patricia; Bloom, Leslie; Zimmerman, Brenda A.; Gu, Joan; Cooper, Kimberly M.; Lynch, Joseph M.

In: Archives of Pediatrics and Adolescent Medicine, Vol. 160, No. 1, 01.01.2006, p. 82-90.

Research output: Contribution to journalArticle

Wilens, TE, McBurnett, K, Bukstein, O, McGough, J, Greenhill, L, Lerner, M, Stein, MA, Conners, CK, Duby, J, Newcorn, J, Bailey, CE, Kratochvil, CJ, Coury, D, Casat, C, Denisco, MJC, Halstead, P, Bloom, L, Zimmerman, BA, Gu, J, Cooper, KM & Lynch, JM 2006, 'Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder', Archives of Pediatrics and Adolescent Medicine, vol. 160, no. 1, pp. 82-90. https://doi.org/10.1001/archpedi.160.1.82
Wilens, Timothy E. ; McBurnett, Keith ; Bukstein, Oscar ; McGough, James ; Greenhill, Laurence ; Lerner, Marc ; Stein, Mark A. ; Conners, C. Keith ; Duby, John ; Newcorn, Jeffrey ; Bailey, Charles E. ; Kratochvil, Christopher J ; Coury, Daniel ; Casat, Charles ; Denisco, Mary Joan C ; Halstead, Patricia ; Bloom, Leslie ; Zimmerman, Brenda A. ; Gu, Joan ; Cooper, Kimberly M. ; Lynch, Joseph M. / Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder. In: Archives of Pediatrics and Adolescent Medicine. 2006 ; Vol. 160, No. 1. pp. 82-90.
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abstract = "Background: Despite the persistence of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known about the efficacy and tolerability of stimulant medications in this age group. Objective: To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system (OROS) methylphenidate. Design: Adolescents (N=220) having a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria. Subjects successfully completing the dose titration phase (n=177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo. Treatment effectiveness was measured using investigator, parent, and adolescent assessments of ADHD. Results: A significant reduction from baseline in the investigator-rated ADHD Rating Scale, the primary efficacy measure, was found with OROS methylphenidate treatment compared with placebo. Similar findings were noted with parent- and adolescent-report measures. Based on a Clinical Global Impression improvement subscale score of much or very much improved, 52{\%} of subjects in the OROS methylphenidate group improved compared with 31{\%} receiving placebo. Thirty-seven percent of subjects required the maximum dosage of 72 mg/d. The incidence of drug-related adverse events was similar between the 2 study groups. Conclusion: In adolescents, once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d.",
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AU - McGough, James

AU - Greenhill, Laurence

AU - Lerner, Marc

AU - Stein, Mark A.

AU - Conners, C. Keith

AU - Duby, John

AU - Newcorn, Jeffrey

AU - Bailey, Charles E.

AU - Kratochvil, Christopher J

AU - Coury, Daniel

AU - Casat, Charles

AU - Denisco, Mary Joan C

AU - Halstead, Patricia

AU - Bloom, Leslie

AU - Zimmerman, Brenda A.

AU - Gu, Joan

AU - Cooper, Kimberly M.

AU - Lynch, Joseph M.

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N2 - Background: Despite the persistence of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known about the efficacy and tolerability of stimulant medications in this age group. Objective: To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system (OROS) methylphenidate. Design: Adolescents (N=220) having a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria. Subjects successfully completing the dose titration phase (n=177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo. Treatment effectiveness was measured using investigator, parent, and adolescent assessments of ADHD. Results: A significant reduction from baseline in the investigator-rated ADHD Rating Scale, the primary efficacy measure, was found with OROS methylphenidate treatment compared with placebo. Similar findings were noted with parent- and adolescent-report measures. Based on a Clinical Global Impression improvement subscale score of much or very much improved, 52% of subjects in the OROS methylphenidate group improved compared with 31% receiving placebo. Thirty-seven percent of subjects required the maximum dosage of 72 mg/d. The incidence of drug-related adverse events was similar between the 2 study groups. Conclusion: In adolescents, once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d.

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