A randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of the methylphenidate transdermal system for the treatment of ADHD in adolescents

CNS Spectrums

Volumn 15, Issue 7, 2010, Pages 419-430

  Findling, Robert L ^a   Turnbow, John ^b   Burnside, John ^c   Melmed, Raun ^d   Civil, Rich ^e   Li, Yunfeng ^f  

^a UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^b Physician Investigator   (United States)

^c UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^d Melmed Center   (United States)

^e Global Clinical Medicine   (United States)

^f SHIRE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

METHYLPHENIDATE; PLACEBO; CENTRAL STIMULANT AGENT;

ADHD RATING SCALE IV; ADOLESCENT; ANOREXIA; APPLICATION SITE DERMATITIS; APPLICATION SITE ERYTHEMA; APPLICATION SITE REACTION; ARTICLE; ATTENTION DEFICIT DISORDER; BLOOD PRESSURE; BODY HEIGHT; BODY MASS; CLINICAL GLOBAL IMPRESSION SCALE; CONNERS PARENT RATING SCALES REVISED SHORT FORM; CONTROLLED STUDY; DEFENSE MECHANISM; DERMAL RESPONSE SCALE; DIZZINESS; DOSE OPTIMIZATION STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; ELECTROCARDIOGRAPHY; FATIGUE; FEMALE; FOLLICULITIS; HEART PALPITATION; HEART RATE; HUMAN; HYPERTENSION; IRRITABILITY; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MOOD DISORDER; MULTICENTER STUDY; OUTCOME ASSESSMENT; PARENT GLOBAL ASSESSMENT; PHASE 3 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; PSORIASIS; PSYCHOMETRY; QRS COMPLEX; RANDOMIZED CONTROLLED TRIAL; SEDATION; SIDE EFFECT; SKIN TEST; SOMNOLENCE; SYNCOPE; TACHYCARDIA; TRANSDERMAL SYSTEM ADHERENCE SCALE; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; VITAL SIGN; WEIGHT GAIN; WEIGHT REDUCTION; XEROSTOMIA; CHEMICALLY INDUCED; DOSE RESPONSE;

ADOLESCENT; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CENTRAL NERVOUS SYSTEM STIMULANTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; HUMANS; METHYLPHENIDATE;

EID: 77958612552     PISSN: 10928529     EISSN: None     Source Type: Journal    
DOI: 10.1017/S1092852900000353     Document Type: Article

References (33)

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.
2. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text-Rev. Washington, DC: American Psychiatric Association; 2000.
3. Wilens TE, Biderman J, Spencer TJ. Attention-deficit/hyperactivity disorder across the lifespan. Annu Rev Med. 2002;53:113-131.
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.
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.
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.
7. Global ADHD Working Group. Global consensus of ADHD/HKD. Eur Child Adolesc Psychiatry. 2005;14(3):127-137.
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.
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.
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.
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.
12. Castle L, Aubert RE, Verbrugge RR, et al. Trends in medication treatment for ADHD. J Atten Disord. 2007;10(4):335-342.
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.
14. Wilens TE. Effects of methylphenidate on the catecholaminergic system in attention-deficit/ hyperactivity disorder. J Clin Psychopharmacol. 2008;28(suppl 2):46S-53S
15. Daytrana [package insert]. Wayne, PA: Shire US Inc.; 2008.
16. Noven Pharmaceuticals Inc. DOT Matrix Technology. Available at: http://www.daytrana. com. Accessed July 3, 2009.
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.
18. McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon, E. A randomized, doubleblind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006;9(3):476-485.
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.
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.
21. Kaufman AS. K-BIT: Kaufman Brief Intelligence Test. Circle Pines, Minnesota: American Guidance Service; 1990.
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.
23. DuPaul G, Power T, Anastopoulos A, et al. ADHD Rating Scale-IV: Checklists, Norms and Clinical Interpretation. New York, NY: Guilford Press; 1998.
24. Conners CK. Conners' Rating Scales-Revised, Technical Manual. New York, NY: MultiHealth Systems, Inc; 1997.
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.
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.
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.
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.
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.
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.
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.
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.
33. McLeod KA. Congenital heart disease: dizziness and syncope in adolescence. Heart. 2001;86(3):350-354.