Objective: This study evaluates the efficacy, duration of action, and tolerability of methylphenidate transdermal system (MTS) in children with ADHD. Method: Participants were dose optimized over 5 weeks utilizing patch doses of 10, 16, 20, and 27 mg applied in the morning and worn for 9 hours. Following optimization, 80 participants were randomized to 1 week of MTS or placebo followed by 1 week of the opposite treatment. Laboratory classroom sessions conducted after each randomized week included blinded ratings of attention, behavior, and academic performance. Results: MTS was well tolerated and displayed significant improvement compared with placebo. Improvements were seen at the first postdose time point measured and continued through 12 hours. Conclusions: Treatment with MTS resulted in statistically significant improvements on all efficacy measures. Time course and therapeutic effects of MTS suggest that this novel methylphenidate delivery system is an efficacious once-daily treatment for ADHD.
American Academy of Pediatrics. (2000). Clinical practice guideline: Diagnosis and evaluation of the child with attention-deficit/hyperactivity disorder. Pediatrics, 105, 1158-1170.
2.
American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders (4th ed., text rev.). Washington, DC: Author.
3.
Biederman, J., Quinn, D., Weiss, M., Markabi, S., Weidenman, M., Edson, K., et al. (2003). Efficacy and safety of Ritalin LA, a new, once-daily, extended-release dosage form of methylphenidate, in children with attention-deficit/hyperactivity disorder. Pediatric Drugs, 5, 833-841.
4.
Conners, C. K. (1997). Conners’ Rating Scales-Revised: Technical manual. New York: Multi-Health System Inc.
5.
Dulcan, M. K., Dunne, J. E., Ayres, W., Arnold, V., Benson, R. S., Bernet, W., et al. (1997). Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 36(Suppl. 10), 85S-121S.
6.
DuPaul, G. J., Power, T. J., Anastopolous, A. D., & Reid, R. (1998). ADHD Rating Scale-IV: Checklists, norms, and clinical interpretation. New York: Guilford.
7.
Greenhill, L. L., Pliszka, S., Dulcan, M. K., Bernet, W., Arnold, V., Beitchman, J., et al. (2002). Practice parameter for the use of stimulant medications in the treatment of children, adolescents and adults. Journal of the American Academy of Child and Adolescent Psychiatry, 41(Suppl. 2), 26S-49S.
8.
Kaufman, A. S., & Kaufman, N. L. (1990). Kaufman Brief Intelligence Test (K-BIT) manual. Circle Pines, MN: AGS Publishing.
9.
Kaufman, J., Birmaher, B., Brent, D., Rao, U., Flynn, C., Moreci, P., et al. (1997). Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADSPL): Initial reliability and validity data. Journal of the American Academy of Child and Adolescent Psychiatry, 36, 980-988.
10.
McCracken, J. T., Biederman, J., Greenhill, L. L., Swanson, J. M., McGough, J. J., Spencer, T. J., et al. (2003). Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD. Journal of the American Academy of Child and Adolescent Psychiatry, 42, 673-683.
11.
MTA Cooperative Group. (1999a). A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56, 1073-1086.
12.
MTA Cooperative Group. (1999b). Moderators and mediators of treatment response for children with attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56, 1088-1096.
13.
Pelham, W. E., Burrows-Maclean, L., Gnagy, E. M., Fabiano, G. A., Coles, E. K., Tresco, K. E., et al. (2005). Transdermal methylphenidate, behavioral, and combined treatment for children with ADHD. Experimental and Clinical Psychopharmacology, 13, 111-126.
14.
Pelham, W. E., Gnagy, E. M., Burrows-Maclean, L., Williams, A., Fabiano, G. A., Morrisey, S. M., et al. (2001). Once-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings. Pediatrics, 107, e105-e119.
15.
Pelham, W. E., Manos, M. J., Ezzell, C. E., Tresco, K. E., Gnagy, E. M., Hoffman, M. T., et al. (2005). A dose-ranging study of a methylphenidate transdermal system in children with ADHD. Journal of the American Academy of Child and Adolescent Psychiatry, 44, 522-529.
16.
Quinn, D., Wigal, S., Swanson, J., Hirsch, S., Ottolini, Y., Dariani, M., et al. (2004). Comparative pharmacodynamics and plasma concentrations of d-threo-methylphenidate hydrochloride after single doses of d-threo-methylphenidate hydrochloride and d, l-threomethylphenidate hydrochloride in a double-blind, placebo-controlled, crossover laboratory school study in children with attention-deficit/hyperactivity disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 43, 1422-1429.
17.
SAS Institute, Inc. (2001). SAS (Version 8.2) [Computer software]. Cary, NC: Author.
18.
Spencer, T. J. (2004). ADHD treatment across the life cycle. Journal of Clinical Psychiatry, 65(Suppl. 3), 22-26.
19.
Stein, M. A., Sarampote, C. S., Waldman, I. D., Robb, A. S., Conlon, C., Pearl, P. L., et al. (2003). A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics, 112, e404-e413.
20.
Swanson, J., Gupta, S., Lam, A., Shoulson, I., Lerner, M., Modi, N., et al. (2003). Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder: proof-of-concept and proof-of-product studies. Archives of General Psychiatry, 60, 204-211.
21.
Swanson, J. M., Agler, D., Fineberg, E., Wigal, S., Flynn, D., Fineberg, K., et al. (2000). University of California, Irvine laboratory school protocol for pharmacokinetic and pharmacodynamic studies. In L. L. Greenhill & B. B. Osman (Eds.), Ritalin: Theory and practice (2nd ed., pp. 405-432). New York: Mary Ann Liebert.
22.
Swanson, J. M., Lerner, M., Wigal, T., Steinhoff, K., Greenhill, L., Posner, K., et al. (2002). The use of a laboratory school protocol to evaluate concepts about efficacy and side effects of new formulations of stimulant medications. Journal of Attention Disorders, 6(Suppl. 1), S73-S88.
23.
Swanson, J. M., Wigal, S., Greenhill, L. L., Browne, R., Waslik, B., Lerner, M., et al. (1998). Analog classroom assessment of Adderall in children with ADHD. Journal of the American Academy of Child and Adolescent Psychiatry, 37, 519-526.
24.
Swanson, J. M., Wigal, S. B., Wigal, T., Sonuga-Barke, E., Greenhill, L. L., Biederman, J., et al. (2004). A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study). Pediatrics, 113, e206-e216.
25.
Wigal, S. B., Gupta, S., Guinta, D., & Swanson, J. (1998). Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharmacology Bulletin, 34, 47-53.
26.
Wolraich, M. L., Greenhill, L. L., Pelham, W., Swanson, J., Wilens, T., Palumbo, D., et al. (2001). Randomized, controlled trial of OROS methylphenidate once a day in children with attention deficit/hyperactivity disorder. Pediatrics, 108, 883-892.
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