Onset of efficacy of long-acting psychostimulants in pediatric attention-deficit/hyperactivity disorder

Postgraduate Medicine

Volumn 120, Issue 3, 2008, Pages 69-88

  Brams, Matthew ^a   Mao, Alice R ^a   Doyle, Robert L ^b  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

ADHD; Amphetamine; Attention deficit hyperactivity disorder; Extended release; Methylphenidate; Sustained release

Indexed keywords

AMPHETAMINE; ATOMOXETINE; DEXMETHYLPHENIDATE; DIFFUCAPS; LISDEXAMFETAMINE; METHYLPHENIDATE; OROS; PLACEBO; SODAS; UNCLASSIFIED DRUG; CENTRAL STIMULANT AGENT;

ADOLESCENT; AREA UNDER THE CURVE; ARTICLE; ATTENTION DEFICIT DISORDER; CHILD; CLINICAL ASSESSMENT; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FORMULATION; DRUG MECHANISM; HUMAN; MAXIMUM PLASMA CONCENTRATION; MEDICAL TECHNOLOGY; MEDLINE; OPTIMAL DRUG DOSE; SUSTAINED RELEASE FORMULATION; SYSTEMATIC REVIEW; TIME TO MAXIMUM PLASMA CONCENTRATION; CASE REPORT; DELAYED RELEASE FORMULATION; FEMALE; MALE; METABOLISM; REVIEW; TREATMENT OUTCOME;

ADOLESCENT; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CENTRAL NERVOUS SYSTEM STIMULANTS; CHILD; DELAYED-ACTION PREPARATIONS; FEMALE; HUMANS; MALE; TREATMENT OUTCOME;

EID: 56149084870     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.3810/pgm.2008.09.1909     Document Type: Article

References (73)

1. National Institutes of Health. Diagnosis and treatment of attention deficit hyperactivity disorder. NIH consensus statement online. 1998;16:1-37. http://www.consensus.nih.gov. Accessed November 22, 2007.
2. Burd L, Klug MG, Coumbe MJ, Kerbeshian J. Children and adolescents with attention deficit-hyperactivity disorder: 1. Prevalence and cost of care. J Child Neurol. 2003;18(8):555-561.
3. Biederman J, Faraone SV. Attention-deficit hyperactivity disorder. Lancet. 2005;366(9481):237-248. (Pubitemid 40981053)
4. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000.
5. Hinshaw SP. Externalizing behavior problems and academic under- achievement in childhood and adolescence: causal relationships and underlying mechanisms. Psychol Bull. 1992;111(1):127-155.
6. Biederman J, Faraone S, Milberger S, et al. A prospective 4-year follow-up study of attention-deficit hyperactivity and related disorders. Arch Gen Psychiatry. 1996;53(5):437-446. (Pubitemid 26149233)
7. Liu YH, Stein MT. Attention-deficit/hyperactivity disorder: evidence-based diagnosis and management for primary care clinicians. Minerva Pediatr. 2004;56(6):567-583. (Pubitemid 43942375)
8. Williams LM, Hermens DF, Palmer D, et al. Misinterpreting emotional expressions in attention-deficit/hyperactivity disorder: evidence for a neural marker and stimulant effects. Biol Psychiatry. 2008; 63(10):917-926.
9. Clarke SD, Kohn MR, Hermens DF, et al. Distinguishing symptom profiles in adolescent ADHD using an objective cognitive test battery. Int J Adolesc Med Health. 2007;9(3):355-367. (Pubitemid 350186417)
10. Escobar R, Hervas A, Soutullo C, Mardomingo M, Uruñuela A, Gilaberte I. Attention deficit/hyperactivity disorder: burden of the disease according to subtypes in recently diagnosed children, [published online ahead of print February 28, 2008]. Actus Esp Psiquiatr.
11. Pelham WE, Foster EM, Robb JA. The economic impact of attention- deficit/hyperactivity disorder in children and adolescents. Ambul Pediatr. 2007;7(1 suppl):121-131. (Pubitemid 46140755)
12. MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. The MTA Cooperative Group. Multimodal Treatment Study of Children with ADHD. Arch Gen Psychiatry. 1999;56(12):1073-1086.
13. Gillberg C, Melander H, von Knorring AL, et al. Long-term stimulant treatment of children with attention-deficit-hyperactivity disorder symptoms: a randomized, double-blind, placebo-controlled trial. Arch Gen Psych. 1997;54(9):857-864. (Pubitemid 27383313)
14. Goldman LS, Genel M, Bezman RJ, Slanetz PS. Diagnosis and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Council on Scientific Affairs, American Medical Association. JAMA. 1998;279(14):1100-11007 (Pubitemid 28177819)
15. Elia J, Ambrosini PJ, Rapoport JL. Treatment of attention- deficit-hyperactivity disorder. N Engl J Med. 1999;340(10):780-788.
16. Faraone SV, Biederman J, Spencer TJ, Aleardi M. Comparing the efficacy of medications for ADHD using meta-analysis. Med Gen Med. 2006;8(4):4. (Pubitemid 44541837)
17. Faraone SV. Understanding the effect size of ADHD medications: implications for clinical care. Medscape Psychiatry and Mental Health 2003:8. http://www.medscape.com/viewarticle/461543. Accessed March 5, 2008.
18. Harris Interactive® fielded an online survey. Data on file. Novartis Pharmaceuticals Corp; 2008.
19. Olfson M. New options in the pharmacological management of attention- deficit/hyperactivity disorder. Am J Manag Care. 2004;10(4 suppl): S117-S124. (Pubitemid 38970247)
20. Pelham WE, Gnagy EM, Burrows-Maclean L, et al. Once-a-day Concerta® methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings. Pediatrics. 2001;107(6):E105.
21. Wolraich ML, Greenhill LL, Pelham W, et al. Randomized, controlled trial of OROS® methylphenidate once a day in children with attention-deficit/ hyperactivity disorder. Pediatrics. 2001;108(4):883-892. (Pubitemid 32947657)
22. Biederman J, Lopez FA, Boellner SW, Chandler MC. A randomized, double-blind, placebo-controlled, parallel-group study of SL1381 (Adderall XR®) in children attention deficif/hyperactivity disorder. Pediatrics. 2002;110(2 pt 1):258-266. (Pubitemid 34833008)
23. Biederman J, Quinn D, Weiss M, et al. Efficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder. Pediatr Drugs. 2003;5(12):833-841. (Pubitemid 38030609)
24. Lopez F, Silva R, Pestreich L, et al. Comparative efficacy of two once daily methylphenidate formulations (Ritalin® LA™ and Concerta®) and placebo in children with attention deficit hyperactivity disorder across the school day. Pediatr Drugs. 2003;5(8):545-555. (Pubitemid 37046766)
25. McCracken JT, Biederman J, Greenhill LL, et al. Analog classroom assessment of a once-daily mixed amphetamine formulation, SL1381 (Adderall XR®), in children with ADHD. J Am Acad Child Adolesc Psychiatry. 2003;42(6):673-683. (Pubitemid 39625053)
26. Swanson JM, Wigal SB, Wigal T, et al; the COMACS Study Group. A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (The COMACS Study). Pediatrics. 2004;113(3 pt 1):e206-e216.
27. Silva R, Pestreich LK, Brams M, Childress A, Lopez FA. Efficacy of two long-acting methylphenidate formulations in children with attention- deficit/hyperactivity disorder in a laboratory classroom setting. J Child Adolesc Psychopharmacol. 2005;15(4):637-654. (Pubitemid 41434368)
28. Wigal SB, McGough JJ, McCracken JT, et al. A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR®) and atomoxetine (Strattera®) in school-aged children with attention- deficit/hypcractivity disorder. J Atten Disords. 2005;9(1):275-289. (Pubitemid 41551759)
29. Greenhill LL, Muniz R, Ball RR, Levine A, Pestreich L, Jiang H. Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45(7):817-823. (Pubitemid 43932908)
30. 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. (Pubitemid 43171141)
31. Silva RR, Muniz R, Pestreich L, et al. Efficacy and duration of effect of extended-release dexmethylphenidate versus placebo in schoolchildren with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2006;16(3):239-251. (Pubitemid 43902421)
32. Biederman J, Krishnan S, Zhang Y, McGough J, Findling R. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007;29(3):450-463. (Pubitemid 46924786)
33. Biederman J, Boellner SW, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo- controlled, crossover analog classroom study. Biol Psychiatry. 2007;62(9):970-976. (Pubitemid 47562371)
34. 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;69:149-159. Erratum in: J Clin Psychiatry. 2008;69(1):329.
35. Muniz R, Brams M, Mao A, McCague K, Silva R. Efficacy and safety of extended-release dexmethylphenidate compared with d, l-methylphenidate and placebo in the treatment of children with attention deficit hyperactivity disorder: A 12-hour laboratory classroom study. J Child Adolesc Psychopharmacol. 2008;18(3):248-256.
36. Silva RR, Muniz R, Pestreich L, et al. Dexmethylphenidate extended- release capsules in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2008;47(2):199-208.
37. Silva R, Muniz R, McCague K, Childress A, Brams M, Mao A. Treatment of children with attention-deficit/hyperactivity disorder: results of a randomized, multicenter, double-blind, crossover study of extended-release dexmethylphenidate and d, l-methylphenidate and placebo in a laboratory classroom setting. Psychopharmacol Bull. 2008;41(1):19-33.
38. Dexedrine* (dextroamphetamine sulfate) spansule sustained-release capsules and tablets [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2007.
39. James RS, Sharp WS, Bastain TM, et al. Double-blind, placebo-controlled study of single-dose amphetamine formulations in ADHD. J Am Acad Child Adolesc Psychiatry. 2001;40(11):1268-1276. (Pubitemid 32995794)
40. Adderall XR* (amphetamine) capsules proscribing information [package insert]. Florence, KY: Shire US Inc. 2007.
41. Concerta® (methylphenidate HCl) extended-release tablets CII [package insert]. Fort Washington, PA: McNeil-PPC, Inc. 2007.
42. Daytrana™ (methylphenidate transdermal system) [package insert]. Wayne, PA: Shire US Inc. 2007.
43. Focalin® XR (dexmethylphenidate hydrochloride) extended-release capsules [package insert]. Summit, NJ: Novartis Pharmaceuticals Corporation; 2007.
44. Metadate CD® (methylphenidate HCl) extended-release capsules [package insert]. Rochester, NY: UCB, Inc. 2007.
45. Ritalin LA® (methylphenidate hydrochloride) extended-release capsules [package insert]. Summit, NJ: Novartis Pharmaceuticals Corporation; 2007.
46. Vyvanse™ (lisdexamfetamine dismesylate) [package insert]. Blacksburg, VA: New River Pharmaceuticals Inc. 2007.
47. Strattera®(atomoxetine HCl). Indianapolis, IN: Eli Lilly and Company; 2007.
48. Swanson J, Wigal S, Greenhill L, et al. Objective and subjective measures of the pharmacodynamic effects of Adderall in the treatment of children with ADHD in a controlled laboratory classroom setting. Psychopharmacol Bull. 1998;34(1):55-60. (Pubitemid 28176302)
49. Wigal S, Gupta S, Guinta D, Swanson JM. Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharmacol Bull. 1998;34(1):47-53. (Pubitemid 28176301)
50. Conners CK. Ratings scales in attention deficit/hyperactivity disorder: in assessment and treatment monitoring. J Clin Psychiatry. 1998;59(suppl 7):24-30. (Pubitemid 28317219)
51. Pelham WE, Milich R, Murphy DA, Murphy HA. Normative data on the IOWA Conners teacher rating scale. J Clin Child Psychol. 1989;18:259-262.
52. DuPaul A, Power T, Anastapolous A, Reid R. ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretation. New York, NY: Guilford Press; 1998.
53. Farics DE, Yalcin I, Harder D, Heiligenstein JH. Validation of the ADHD Rating Scale as a clinician administered and scored instrument. J Atten Disord. 2001;5:39-47. (Pubitemid 33794656)
54. Swanson JM, Agler D, Fineberg E, et al. University of California, Irvine, laboratory school protocol for pharmacokinetic and pharmacodynamic studies. In: Greenhill LL, Osman BB, eds. Ritalin: Theory and Practice. New York: Mary Ann Liebert; 2000:405-432.
55. Swanson J, Lerner M, Wigal T, et al. The use of a laboratory school protocol to evaluate concepts about efficacy and side effects of new formulations of stimulant medications. J Atten Disord. 2002; 6(suppl 1):S73-S88.
56. Brown RT, Amler RW, Freeman WS, et al; American Academy of Pediatrics Committee on Quality Improvement; American Academy of Pediatrics Subcommittee on Attention-Deficit/Hyperactivity Disorder. Treatment of attention-deficit/ hyperactivity disorder: overview of the evidence. Pediatrics. 2005;115(6):c749-e757.
57. Ding YS, Fowler JS, Volkow ND, Logan J, Galley SJ, Sugano Y. Carbon-11-d-threo-methylphenidate binding to dopamine transporter in baboon brain. J Nucl Med. 1995;36(12):2298-2305.
58. Ding YS, Fowler JS, Volkow ND, Logan J, Gatley SJ, Sugano Y. Chiral drugs: comparison of the pharmacokinetics of [11C]d-threo and L-threomethylphenidate in the human and baboon brain. Psychopharmacology (Berl). 1997;131(1):71-80. (Pubitemid 27242857)
59. 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. (Pubitemid 44373701)
60. Volkow ND, Fowler JS, Wang G, Ding Y, Gatley SJ. Mechanism of action of methylphenidate: insights from PET imaging studies. J Atten Disord. 2002;6(suppl 1):S31-S43.
61. Quinn D, Wigal S, Swanson J, et al. Comparative pharmacodynamics and plasma concentrations of d-threo-methylphenidate hydrochloride after single doses of d-threo-methylphenidate hydrochloride and d, l-threo-methylphenidate hydrochloride in a double-blind, placebo- controlled, crossover laboratory school study in children with attention- deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatiy. 2004;43(11):1422-1429. (Pubitemid 39411043)
62. Wigal S, Swanson JM, Feifel D, et al. A double-blind, placebo-controlled trial of dexmethylphenidate hydrochloride and d,l-threo-methylphenidate hydrochloride in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatiy. 2004;43(11):1406-1414. (Pubitemid 39411041)
63. Arnold LE, Lindsay RI, Conners CK, et al. A double-blind, placebo-controlled withdrawal trial of dexmethylphenidate hydrochloride in children with attention deficit hyperactivity disorder. J Child Adolesc Psychopharmacol. 2004;14(4):542-554.
64. Swanson J, Gupta S, Lam A, et al. 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. Arch Gen Psychiatry. 2003;60(2):204-211. (Pubitemid 36173129)
65. Krishnan SM, Stark JG. Multiple daily-dose pharmacokinetics of lisdexamfetamine dimesylate in health adult volunteers Curr Med Res Opin. 2008;24(1):33-40.
66. Wilens TE, Dodson W. A clinical perspective of attention- deficit/hyperactivity disorder into adulthood. J Clin Psychiatry. 2004;65(10):1301-1313.
67. Dickstein SG, Bannon K, Castellanos FX, Milliam MP. The neural correlates of attention deficit hyperactivity disorder: an ALE meta-analysis. J Child Psychol Psychiatry. 2006;47(10):1051-1062. (Pubitemid 44642434)
68. Mattay VS, Berman KF, Ostrem JL, et al. Dextroamphetamine enhances "neural network-specific" physiological signals: a positron-emission tomography rCBF study. J Neurosci. 1996;16(15):4816-4822. (Pubitemid 26255289)
69. Volkow ND, Wang GJ, Fowler JS, Ding YS. Imaging the effects of methylphenidate on brain dopamine: new model on its therapeutic actions for attention-deficit/hyperactivity disorder. Biol Psychiatry. 2005;57(11):1410- 1415. (Pubitemid 40798562)
70. Volkow ND, Wang GJ, Fowler JS, et al. Dopamine transporter occupancies in the human brain induced by therapeutic doses of oral methylphenidate. Am J Psychiatry. 1998;155(10):1325-1331. (Pubitemid 28471187)
71. Volkow ND, Wang G, Fowler JS, et al. Therapeutic doses of oral methylphenidate significantly increase extracellular dopamine in the human brain. J Neurosci. 2001;21(2):RC121.
72. Markowitz JS, Straughn AB, Patrick KS. Advances in the pharmacotherapy of attention-deficit-hyperactivity disorder: focus on methylphenidate formulations. Pharmacotherapy. 2003;23(10):1281-1299. (Pubitemid 37221923)
73. Greenhill LL, Pliszka S, Dulcan M, 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): S26-S49.