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

Volumn 60, Issue 2, 2003, Pages 204-211

  Swanson, James ^a   Gupta, Suneel ^b   Lam, Andrew ^b   Shoulson, Ira ^c   Lerner, Marc ^a   Modi, Nishit ^b   Lindemulder, Elizabeth ^b   Wigal, Sharon ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b ALZA CORPORATION   (United States)

^c UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

METHYLPHENIDATE;

ADOLESCENT; ARTICLE; ATTENTION DEFICIT DISORDER; CLINICAL ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DRUG ACTIVITY; DRUG ADMINISTRATION; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG RELEASE; HUMAN; SCHOOL CHILD; SUSTAINED RELEASE PREPARATION; TACHYPHYLAXIS; TREATMENT PLANNING;

ADMINISTRATION, ORAL; ADOLESCENT; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CAPSULES; CENTRAL NERVOUS SYSTEM STIMULANTS; CHILD; CLINICAL PROTOCOLS; COHORT STUDIES; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG DELIVERY SYSTEMS; HUMANS; INTESTINAL ABSORPTION; METHYLPHENIDATE; PLACEBOS; TACHYPHYLAXIS; TREATMENT OUTCOME;

EID: 0037317368     PISSN: 0003990X     EISSN: None     Source Type: Journal    
DOI: 10.1001/archpsyc.60.2.204     Document Type: Article

References (30)

1. Eisenberg L, Lachman R, Molling P, Lockner A, Mizelle J, Conners C. A psychopharmacologic experiment in a training school for delinquent boys: methods, problems, and findings. Am J Orthopsychiatry. 1961;33:431-447.
2. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Washington, DC: American Psychiatric Association; 1994.
3. Greenhill L, Halperin J, Abikoff H. Stimulant medications. J Am Acad Child Adolesc Psychiatry. 1999;35:1304-1313.
4. Swanson J, Lerner M, Williams L. More frequent diagnosis of attention deficithyperactivity disorder [letter]. N Engl J Med. 1995;333:944.
5. Swanson JM, Kinsbourne M, Roberts W, Zucker K. A time-response analysis of the effect of stimulant medication on the learning ability of children referred for hyperactivity. Pediatrics. 1978;61:21-29.
6. Solanto MV, Conners CK. A dose-response and time-action analysis of autonomic and behavorial effects of methylphenidate in attention deficit disorder with hyperactivity. Psychophysiology. 1982;19:658-667.
7. Greenhill LL. Attention-deficit hyperactivity disorder: the stimulants. Pediatr Psychopharmacol. 1995;4:123-168.
8. Schachar RJ, Tannock R, Cunningham C, Corkum PV. Behavioral, situational, and temporal effects of treatment of ADHD with methylphenidate. J Am Acad Child Adolesc Psychiatry. 1997;36:754-763.
9. Kent JD, Blader JC, Koplewicz HS, Abikoff H, Foley CA. Effects of late-afternoon methylphenidate administration on behavior and sleep in attention-deficit hyperactivity disorder. Pediatrics. 1995;96(pt 1):320-325.
10. MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder. Arch Gen Psychiatry. 1999;56: 1073-1086.
11. Swanson J, Gupta S, Guinta D, Flynn D, Agler D, Lerner M, Williams L, Shoulson I, Wigal S. Acute tolerance to methylphenidate in the treatment of attention deficit hyperactivity disorder in children. Clin Pharmacol Ther. 1999;66:295-305.
12. Patrick KS, Straughn AB, Jarvi EJ, Breese GR, Meyer MC. The absorption of sustained-release methylphenidate formulations compared to an immediaterelease formulation. Biopharm Drug Dispos. 1989;10:165-171.
13. Birmaher B, Greenhill LL, Cooper TB, Fried J, Mainski B. Sustained-release methylphenidate: pharmacokinetic studies in ADHD males. J Am Acad Child Adolesc Psychiatry. 1989;28:768-772.
14. Pelham WE, Sturges J, Hoza J, Schmidt C, Bijlsma JJ, Milich R, Moore S. Sustained-release and standard methylphenidate effects on cognitive and social behavior in children with attention deficit disorder. Pediatrics. 1987;80:491-501.
15. Pelham WE, Greenslade KE, Vodde-Hamilton M, Murphy DA, Greensite JJ, Gnagy EM, Guthrie KJ, Hoover MD, Dahl RE. The efficacy of long-acting stimulants on ADHD children: a comparison of standard methylphenidate, Ritalin-SR, Dexedrine Spansule, and Pemoline. Pediatrics. 1990;86:226-237.
16. Greenhill LL, Osman BB, eds. Ritalin: Theory and Patient Management. New York, NY: Mary Ann Liebert Publishers; 1999.
17. Wigal T, Swanson JM, Regino R, Lerner M, Soliman I, Steinhoff K, Gurbani S, Wigal S. Stimulant medications for the treatment of ADHD: efficacy and limitations. Ment Retard Dev Disabil Res Rev. 1999;5:215-224.
18. Greenhill LL, Abikoff HB, Arnold LE, Cantwell DP, Conners CK, Elliott G, Hechtman L, Hinshaw SP, Hoza B, Jensen PS, March J, Newcorn J, Pelham WF, Severe JB, Swanson JM, Vitiello B, Wells K. Medication treatment strategies in the MTA Study: relevance to clinicians and researchers. J Am Acad Child Adolesc Psychiatry. 1996;35:1-10.
19. Swanson JM, Kraemer HC, Hinshaw SP, Arnold LE, Conners CK, Abikoff HB, Clevenger W, Davies M, Elliott G, Greenhill LL, Hechtman L, Hoza B, Jensen PS, March JS, Newcorn JH, Owens L, Pelham WE, Schiller E, Severe J, Simpson S, Vitiello B, Wells CK, Wigal T, Wu M. Clinical relevance of the primary findings of the MTA: success rates based on severity of ADHD and ODD symptoms at the end of treatment. J Am Acad Child Adolesc Psychiatry. 2001;40:168-179.
20. Greenhill LL, Swanson JM, Vitiello B, Davies M, Clevenger W, Wu M, Severe JB, Arnold LE, Abikoff HB, Conners CK, Elliott G, Hechtman L, Hinshaw SP, Hoza B, Jensen PS, Kraemer HC, March JS, Newcorn JH, Pelham WE, Wells K, Wigal T. Impairment and deportment responses to different methylphenidate doses in children with ADHD: the MTA titration: determining the best dose of methylphenidate under controlled conditions: lessons from the MTA titration. J Am Acad Child Adolesc Psychiatry. 2001;40:180-186.
21. Swanson JM, Agler D, Fineberg E, Wigal S, Flynn D, Fineberg K, Quintana Y, Talebi H. The UCI Lab School Protocol for pharmacokinetic and pharmacodynamic studies. In: Greenhill L, Osman B, eds. Ritalin: Theory and Practice. 2nd ed. New York, NY: Mary Ann Liebert Inc; 1999:405-430.
22. Swanson JM, Wigal SB, Udrea D, Lerner M, Agler D, Mylnn D, Fineberg E, Davies M, Kardatzke D, Ram A, Gupta S. Evaluation of individual subjects in the analog classroom setting, I: examples of graphical and statistical procedures for within-subject ranking of responses to different delivery patterns of methylphenidate. Psychopharmacol Bull. 1998;34:825-832.
23. Wigal SB, Gupta S, Guinta D, Swanson JM. Reliability and validity of the SKAMP Rating Scale in a laboratory school setting. Psychopharmacol Bull. 1998;34:47-53.
24. Park K, Verotta D, Gupta SK, Sheiner LB. Use of a pharmacokinetic/pharmacodynamic model to design an optimal dose input profile. J Pharmacokinet Biopharm. 1998;26:471-492.
25. Swanson JM, Volkow N. Pharmacokinetic and pharmacodynamic properties of methylphenidate in humans: implications for agonist and antagonist theories. In: Solanto M, Arnsten A, Castellanos F, eds. Stimulant Drugs and ADHD Basic and Clinical Neuroscience. Oxford, England: Oxford University Press; 2001:259-282.
26. Volkow ND, Ding YS, Fowler JS, Wang GJ, Logan J, Gatley JS, Dewey S, Ashby C, Liebermann J, Hitzemann R, Wolf AP. Is methylphenidate like cocaine? studies on their pharamcokinetic and distribution in human brain. Arch Gen Psychiatary. 1995;52:456-463.
27. Loney J, Milich R. Hyperactivity, inattention, and aggression in clinical practice. In: Wolraich M, Routh DK, eds. Advances in Development and Behavioral Pediatrics. Greenwich, Conn: JAI Press Inc; 1982;3:113-147.
28. Cohen J. Statistical Power Analysis for the Behavioral Sciences. New York, NY: Academic Press; 1977.
29. Jones B, Kenward M. Design and Analysis of Crossover Trials. London, England: Chapman & Hall; 1989.
30. Swanson J, Greenhill L, Pelham W, Wilens T, Wolraich M, Abikoff H, Atkins M, August G, Biederman J, Bukstein O, Conners CK, Efron L, Fiebelkorn K, Fried J, Hoffman M, Lambrecht L, Lerner M, Leventhal B, McBurnett K, Morse E, Palumbo D, Pfiffner L, Stein M, Wigal S, Winans E. Initiating Concerta (OROS- methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder. J Clin Res. 2000;3:59-76.