A randomized, controlled, effectiveness trial of oros-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit- hyperactivity disorder

Canadian Journal of Clinical Pharmacology

Volumn 13, Issue 1, 2006, Pages

  Steele, Margaret ^a   Weiss, Margaret ^b   Swanson, James ^c,d   Wang, Jenny ^e   Prinzo, Rosanna S ^f   Binder, Carin E ^f  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d WEILL CORNELL MEDICAL CENTER   (United States)

^e Covar Inc ^*  (Canada)

^f Janssen Inc Medical Affairs   (Canada)

Author keywords

Attention Deficit Hyperactivity Disorder (ADHD); Immediate release methylphenidate (IR MPH); OROS methylphenidate (OROS MPH); SNAP IV parent rating scale

Indexed keywords

GENERIC DRUG; METHYLPHENIDATE;

ABDOMINAL PAIN; AGITATION; ARTICLE; ATTENTION DEFICIT DISORDER; AUTISM; BEHAVIOR DISORDER; CHILD; CLINICAL FEATURE; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; DECREASED APPETITE; DRUG DOSAGE FORM COMPARISON; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG STORAGE; DRUG TOLERABILITY; FATIGUE; FEMALE; FLU LIKE SYNDROME; HEADACHE; HUMAN; IMPULSIVENESS; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MENTAL INSTABILITY; MULTICENTER STUDY; NERVOUSNESS; NEUROLOGIC DISEASE; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; REMISSION; SIDE EFFECT; SLEEP DISORDER; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; VISUAL ANALOG SCALE;

ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CHEMISTRY, PHARMACEUTICAL; CHILD; DELAYED-ACTION PREPARATIONS; FEMALE; HUMANS; MALE; METHYLPHENIDATE;

EID: 33645740561     PISSN: 1198581X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (36)

1. Mannuzza S, Klein RG, Bessler A, Malloy P, La Padula M. Adult outcome of hyperactive boys. Educational achievement, occupational rank, and psychiatric status. Arch Gen Psychiatry 1993;50:565-76.
2. Cox D, Merkel RL, Penberthy JK, Kovatchev B, Hankin, CS. Impact of Methylphenidate delivery profile on driving performance of adolescents with Attention-Deficit/Hyperactivity Disorder: A pilot study. J Am Acad Child Adolesc Psychiatry 2004;43:3.
3. Guevara J, Lozano P, Wickizer T, Mell L, Gephart H. Utilization and cost of health care services for children with attention-deficit/hyperactivity disorder. Pediatrics 2001;108:71-8.
4. Chan E, Zhan C, Homer CJ. Health care use and costs for children with attention-deficit/hyperactivity disorder: national estimates from the medical expenditure panel survey. Arch Pediatr Adolesc Med 2002;156:504-11.
5. Leibson CL, Katusic SK, Barbaresi WJ, Ransom J, O'Brien PC. Use and costs of medical care for children and adolescents with and without attention deficit/hyperactivity disorder. JAMA 2001;285:60-6.
6. American Academy of Child and Adolescent Psychiatry. 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.
7. MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for attention deficit/hyperactivity disorder. Arch Gen Psychiatry 1999;56:1073-86.
8. Swanson JM, Kraemer HC, Hinshaw SP, et al. 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;40:168-79.
9. 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;60:204-11.
10. Greenhill LL, Pliszka S, Dulcan MK, et al. Summary of the practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry 2001;40:1352-5.
11. Biederman J, Spencer T. Methylphenidate in treatment of adults with Attention-Deficit/Hyperactivity Disorder J Atten Disord 2002;6(Suppl 1):S101-7.
12. Adesman AR. New medications for treatment of children with attention-deficit/ hyperactivity disorder: review and commentary. Pediatr Ann 2002;31:514-22.
13. nd edition. Larchmont (NY): Mary Ann Liebert Inc., 2000.
14. Pelham WE, Greenslade KE, Vodde-Hamilton M, et al. Relative efficacy of long-acting stimulants on children with attention deficit-hyperactivity disorder: a comparison of standard methylphenidate, sustained-release methylphenidate, sustained-release dextroamphetamine, and pemoline. Pediatrics 1990;86:226-37.
15. Swanson JM, Gupta S, Williams L, Agler D, Lerner M, Wigal S. Efficacy of a new pattern of delivery of methylphenidate for the treatment of ADHD: Effects on activity level in the classroom and on the playground. J Am Acad Child Adolesc Psychiatry 2002;41:1306-14.
16. Concerta® Product Monograph, prepared June 18, 2003. Inc., Toronto, Ontario, Canada.
17. 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. Available at: http://www.pediatrics.org/cgi/ content/full/107/6/e105.
18. 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;108:883-92.
19. March JS, Silva, SG, Compton S, Shapiro M, Califf R, Krishnan R. The case for Practical Clinical Trials in Psychiatry. Am J Psychiatry 2005;162:836-846.
20. American Psychiatric Association: Diagnostic and statistical manual of mental disorders, Fourth edition (DSM-IV). Washington (DC): American Psychiatric Press, 1994.
21. Swanson J. School-Based Assessments and Interventions for ADD Students. Irvine (CA): K. C. Publishing, 1992.
22. Loney J, Milich R. Hyperactivity, inattention, and aggression in clinical practice. In: Wolraich M, Routh DK, eds. Advances in Behavioral Pediatrics. Greenwich (CT): JAI Press, 1982:113-147.
23. Pelham WE, Milich R, Murphy DA, Murphy HA. Normative data on the IOWA Conners teacher rating scales. J Clin Child Psychol 1989;18:259-62.
24. Goyette CH, Conners CK, Ulrich RF. Normative data on revised Conners parent and teacher rating scales. J Abnorm Child Psychol 1978;6:221-36.
25. Abidin R, Loyd BH. Revision of the Parenting Stress Index. J Pediatr Psychol 1985;10:169-77.
26. Anastopoulos AD, Shelton TL, DuPaul GJ, Guevremont DC. Parenting training for Attention Deficit Hyperactivity Disorder: Its impact on parent functioning. J of Abnorm Child Psychol 1993;21:581-96.
27. Johnston C, Marsh EJ. Families of children with attention-deficit/ hyperactivity disorder: review and recommendations for future research. Clin Child Fam Psychol Rev 2001;4:183-207.
28. Pelham WE, Lang AR. Can your children drive you to drink? Stress and parenting in adults interacting with children with ADHD. Alcohol Res Health 1999;23:292-8.
29. Anastopoulos AD, Guevremont DC, Shelton TL, DuPaul GJ. Parenting stress among families of children with Attention Deficit Hyperactivity Disorder. J Abnorm Child Psychol 1992;20:503-20.
30. Breen MJ, Barkley RA. Child psychopathology and parenting stress in girls and boys having Attention Deficit Disorder With Hyperactivity. J of Ped Psychol 1988;13(2):265-80.
31. Dowell J, Hudson H. A qualitative study of medication-taking behaviour in primary care. Family Practice 1997;14:369-375.
32. Brown RT, Borden KA, Wynne ME, Spunt AL, Clingerman SR. Compliance with pharmacological and cognitive treatments for Attention Deficit Disorder. J Am Acad Child Adolesc Psychiatry 1987;26:521-6.
33. Johnston C, Fine S. Methods of evaluating methylphenidate in children with attention deficit hyperactivity disorder: acceptability, satisfaction, and compliance. J Pediatr Psychol 1993;18:717-30.
34. Kutcher S, Aman M, Brooks SJ, et al. International consensus statement on attention-deficit/hyperactivity disorder (ADHD) and disruptive behaviour disorders (DBDs): Clinical implications and treatment practice suggestions. Eur Neuropsychopharmacol 2004;14:11-28.
35. MTA Cooperative Group. National Institute of Mental Health Multimodal Treatment Study of ADHD Follow-up: 24-Month Outcomes of Treatment Strategies for Attention-Deficit/Hyperactivity Disorder. Pediatrics 2004;113:755-61.
36. Pliszka SR, Lopez M, Crismon ML, et al. A feasibility study of the children's medication algorithm project (CMAP) algorithm for the treatment of ADHD. J Am Acad Child Adolesc Psychiatry 2003;42:279-87.