A RANDOMIZED, CONTROLLED, EFFECTIVENESS TRIAL OF OROS- METHYLPHENIDATE COMPARED TO USUAL CARE WITH IMMEDIATE-RELEASE METHYLPHENIDATE IN ATTENTION DEFICIT- HYPERACTIVITY DISORDER
Main Article Content
Keywords
OROS® methylphenidate (OROS-MPH), immediate-release methylphenidate (IR-MPH), Attention-Deficit/Hyperactivity Disorder (ADHD), SNAP-IV parent-rating scale
Abstract
Background
The thrice daily dosing regimen of immediate release methylphenidate (IR-MPH) for Attention Deficit/Hyperactivity Disorder (ADHD) requires in-school dosing, leading to issues surrounding dispensing and storage of controlled substances by school personnel and concerns over children’s privacy and the embarrassment associated with taking medication in public at school. OROS-Methylphenidate (OROS-MPH) is a once-daily controlled-release formulation of methylphenidate (MPH) developed to overcome some of the limitations associated with IR-MPH and first-generation sustained-release formulations. Randomized, controlled trials (RCTs) that focus on treatment efficacy provide the best evidence for demonstrating whether an intervention works, but under ideal conditions one cannot discount the importance of efficacy study results. However, the most useful information to clinicians comes from an effectiveness study design.
Objectives
To evaluate the effectiveness and tolerability of OROS-MPH versus usual care with IR-MPH in children aged 6 to 12 years with ADHD.
Methods
This 8 week, multicentre, open-label study randomized 147 subjects to either once-daily OROS-MPH or usual care with IR-MPH. Subjects were titrated to a clinically effective dose of either study medication over 4 weeks and maintained on that dose for an additional 4 weeks. The SNAP-IV parent-rating scale was used to assess effectiveness.
Results
OROS-MPH showed statistically significant superiority to IR-MPH in remission rate based on the 18 ADHD symptoms (p=0.0002, X2=13.8, df=1) and severity of ADHD and ODD symptoms (p=0.004, F=8.4, df=1,127), as well as on the following secondary assessments: IOWA Conners, Conners Parent Rating Scale (short version), Parent Stress Index, (short version); Visual Analogue Scale for social play; Clinical Global Impression-Severity, Clinical Global Impression-Improvement and Parent Satisfaction with treatment. OROS-MPH and IR-MPH were both well tolerated with a similar side effect profile.
Conclusions
Once-daily OROS-MPH is significantly more effective than usual care with IR-MPH based on multiple outcome measures including remission rate.
References
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. Greenhill LL, Osman BB. Ritalin. Theory and Practice, 2nd 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/e1 05.
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, 994.
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.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.