Hostname: page-component-586b7cd67f-r5fsc Total loading time: 0 Render date: 2024-11-22T07:09:51.508Z Has data issue: false hasContentIssue false
  • English
  • Français

A Randomized, Double-Blind, Multicenter, Parallel-Group, Placebo-Controlled, Dose-Optimization Study of the Methylphenidate Transdermal System for the Treatment of ADHD in Adolescents

Published online by Cambridge University Press:  07 November 2014

Robert L. Findling ,
John Turnbow ,
John Burnside ,
Raun Melmed ,
Rich Civil  and
Yunfeng Li
Get access Rights & Permissions [Opens in a new window]

Abstract

Introduction: The current report evaluates the efficacy and safety of methylphenidate transdermal system (MTS) compared with placebo transdermal system (PTS) in adolescents with attention-deficit/hyperactivity disorder (ADHD).

Methods: A total of 217 subjects participated in a 7-week, randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of MTS (10-, 15-, 20- or 30-mg/9 hours). Subjects were randomized into a 2:1 MTS to PTS ratio and titrated to an optimal dose during an initial 5-week period. Subjects maintained their optimal dose through a subsequent 2-week period. The primary outcome measure was the ADHD Rating Scale-IV (ADHD-RS-IV). Safety of MTS was assessed throughout the study by analyzing adverse events, results of physical examinations, laboratory evaluations, vital sign data, electrocardiograms, and dermal evaluations.

Results: Treatment with MTS demonstrated greater reductions from baseline in ADHD-RS-IV total score compared to PTS at endpoint (P <.0001). The majority of the adverse events (98.5%) were mild or moderate in intensity, the most common of which were decreased appetite, headache, irritability, and upper respiratory tract infection. Three subjects in the MTS group discontinued because of an application site reaction.

Conclusions: MTS therapy was generally well-tolerated and resulted in significantly greater improvements in ADHD symptoms in adolescents when compared to PTS.

Type
Original Research
Information
CNS Spectrums , Volume 15 , Issue 7 , July 2010 , pp. 419 - 430
Copyright
Copyright © Cambridge University Press 2010

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Bloom, B, Dey, AN, Freeman, G. Summary health statistics for US children: National Health Interview Survey, 2005. Vital Health Stat 10. 2006;231:1–84.Google Scholar
2.Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text-Rev. Washington, DC: American Psychiatric Association; 2000.Google Scholar
3.Wilens, TE, Biderman, J, Spencer, TJ. Attention-deficit/hyperactivity disorder across the lifespan. Annu Rev Med. 2002;53:113–131.CrossRefGoogle ScholarPubMed
4.Jensen, PS. Clinical considerations for the diagnosis and treatment of ADHD in the managed cared setting. Am J Manag Care. 2009;15(suppl 5):S129–S140.Google Scholar
5.Pliszka, S. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894–922.CrossRefGoogle ScholarPubMed
6. American Academy of Pediatrics Committee on Quality Improvement, Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical practice guideline: treatment of the schoolaged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108(4):1033–1044.CrossRefGoogle Scholar
7.Global ADHD Working Group. Global consensus of ADHD/HKD. Eur Child Adolesc Psychiatry. 2005;14(3):127–137.CrossRefGoogle Scholar
8.Pliszka, SR, Crimson, ML, Hughes, CW, et al. The Texas Children's Medication Algorithm Project: revision of the algorithm for the pharmacotherapy of attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45(6):642–657.CrossRefGoogle ScholarPubMed
9.Greenhill, LL, Pliszka, S, Dulcan, MK, et al. Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry. 2002;41(suppl 2):26S–49S.CrossRefGoogle ScholarPubMed
10.Kutcher, S, Aman, M, Brooks, SJ, et al. International consensus statement on attention-deficit/hyperactivity disorder (ADHD) and disruptive behavior disorders (DBDs): clinical implications and treatment practice suggestions. Eur Neuropsychopharmacol. 2004;14(1):11–28.CrossRefGoogle ScholarPubMed
11.Brinker, A, Mosholder, A, Schech, SD, et al. Indication and use of drug products used to treat attention-deficit/hyperactivity disorder: a cross-sectional study with interference on the likelihood of treatment in adulthood. J Child Adolesc Psychopharmacol. 2007;17(3):328–335.CrossRefGoogle Scholar
12.Castle, L, Aubert, RE, Verbrugge, RR, et al. Trends in medication treatment for ADHD. J Atten Disord. 2007;10(4):335–342.CrossRefGoogle ScholarPubMed
13.Bush, G, Spencer, TJ, Holmes, J, et al. Functional magnetic resonance imaging of methylphenidate and placebo in attention-deficit hyperactivity disorder during the multi-source interference task. Arch Gen Psychiatry. 2008;65(1):102–114.CrossRefGoogle ScholarPubMed
14.Wilens, TE. Effects of methylphenidate on the catecholaminergic system in attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2008;28(suppl 2):46S–53S.CrossRefGoogle ScholarPubMed
15. Daytrana [package insert]. Wayne, PA: Shire US Inc.; 2008.Google Scholar
16. Noven Pharmaceuticals Inc. DOT Matrix Technology. Available at: http://www.daytrana.com. Accessed July 3, 2009.Google Scholar
17.Heal, DJ, Pierce, DM. Methylphenidate and its isomers: their role in the treatment of attention-deficit hyperactivity disorder using a transdermal delivery system. CNS Drugs. 2006;20(9):713–738.CrossRefGoogle ScholarPubMed
18.McGough, JJ, Wigal, SB, Abikoff, H, Turnbow, JM, Posner, K, Moon, E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006;9(3):476–485.CrossRefGoogle ScholarPubMed
19.Findling, RL, Bukstein, OG, Melmed, RD, et al. A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008;69(1):149–159.CrossRefGoogle ScholarPubMed
20.Wilens, TE, Boellner, SW, López, FA, et al. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008;47(6):700–708.CrossRefGoogle ScholarPubMed
21.Kaufman, AS. K-BIT: Kaufman Brief Intelligence Test. Circle Pines, Minnesota: American Guidance Service; 1990.Google Scholar
22.Kaufman, J, Birmaher, B, Brent, D, et al. Schedule for affective disorders and schizophrenia for school-aged children-present and lifetime version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997;36(7):980–988.CrossRefGoogle Scholar
23.DuPaul, G, Power, T, Anastopoulos, A, et al. ADHD Rating Scale-IV: Checklists, Norms and Clinical Interpretation. New York, NY: Guilford Press; 1998.Google Scholar
24.Conners, CK. Conners' Rating Scales–Revised, Technical Manual. New York, NY: Multi-Health Systems, Inc.; 1997.Google Scholar
25.US Department of Health, Education, and Welfare. Clinical global impressions. In: ECDEU Assessments Manual for Psychopharmacology, Revised. Rockville, MD: National Institute of Mental Health; 1976:217–222. Pub. No. (ADM) 76-338.Google Scholar
26.Rapport, MD, Moffitt, C. Attention deficit/hyperactivity disorder and methylphenidate. A review of height/weight, cardiovascular, and somatic complaint side effects. Clin Psychol Rev. 2002;22(8):1107–1131.CrossRefGoogle ScholarPubMed
27.Spencer, TJ, Biederman, J, Wilens, TE. Efficacy and tolerability of long-term, open-label, mixed amphetamine salts extended release in adolescents with ADHD. CNS Spectr. 2005;10 (10 Suppl 15):14–21.CrossRefGoogle Scholar
28.Spencer, TJ, Wilens, TE, Biederman, J, et al. Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of attention-deficit/hyperactivity disorder in adolescent patients: a 4-week, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006;28(2):266–279.CrossRefGoogle ScholarPubMed
29.Wilens, TW, McBurnett, K, Bukstein, O, et al. Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder. Arch Pediatr Adolesc Med. 2006;160(1):82–90.CrossRefGoogle ScholarPubMed
30.Wilens, TE, Pelham, W, Stein, M, et al. ADHD treatment with once-daily OROS methylphenidate: interim 12-month results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry. 2003;42(4):424–433.CrossRefGoogle ScholarPubMed
31.McGough, JJ, Biederman, J, Wigal, SB, et al. Long-term tolerability and effectiveness of once-daily mixed amphetamine salts (Adderall XR) in children with ADHD. J Am Acad Child Adolesc Psychiatry. 2005;44(6):530–538.CrossRefGoogle ScholarPubMed
32.Kratochvil, CJ, Wilens, TE, Greenhill, LL, et al. Effects of long-term atomoxetine treatment for young children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45(8):919–927.CrossRefGoogle ScholarPubMed
33.McLeod, KA. Congenital heart disease: dizziness and syncope in adolescence. Heart. 2001;86(3):350–354.Google Scholar