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Clinical Response and Symptomatic Remission in Children Treated With Lisdexamfetamine Dimesylate for Attention-Deficit/Hyperactivity Disorder

Published online by Cambridge University Press:  07 November 2014

Robert L. Findling ,
Ben Adeyi ,
Gary Chen ,
Bryan Dirks ,
Thomas Babcock ,
Brian Scheckner ,
Robert Lasser ,
Michael L. Pucci ,
Huda I. Abdullah  and
James J. McGough
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Abstract

Objective: To examine clinical response and symptomatic remission in two studies of lisdexamfetamine dimesylate (LDX) in children with attention-deficit/hyperactivity disorder (ADHD).

Methods: In a 4-week, placebo-controlled, double-blind trial, children 6–12 years of age with ADHD received LDX (30–70 mg/day) or placebo. In an open-label trial, children from previous studies were titrated to optimal dose over 4 weeks and maintained up to 1 year. Primary and secondary efficacy assessments were the ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions-Improvement (CGI-I) scale, respectively. Clinical response was defined as ≥30% reduction in ADHD-RS-IV total score with a CGI-I rating of 1 or 2; symptomatic remission was defined by ADHD-RS-IV total score ≤18.

Results: In the 4-week study (N=285), at any postdose assessment, 79.3% achieved response (median 13 days) and 67.1% achieved remission (median 22 days) with LDX versus 29.2% and 23.6% with placebo. In the long-term study (N=251), at any postdose assessment, 96.0% responded and 62.7% maintained response; 88.8% achieved remission and 46.4% maintained remission.

Conclusion: Most children treated with LDX achieved clinical response and symptomatic remission at one time point; once achieved, almost half maintained remission.

Type
Original Research
Information
CNS Spectrums , Volume 15 , Issue 9 , September 2010 , pp. 559 - 568
Copyright
Copyright © Cambridge University Press 2010

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References

REFERENCES

1.Froehlich, TE, Lanphear, BP, Epstein, JN, Barbaresi, WJ, Katusic, SK, Kahn, RS. Prevalence, recognition, and treatment of attention-deficit/hyperactivity disorder in a national sample of US children. Arch Pediatr Adolesc Med. 2007;161(9):857–864.CrossRefGoogle Scholar
2.Faraone, SV, Sergeant, J, Gillberg, C, Biederman, J. The worldwide prevalence of ADHD: is it an American condition? World Psychiatry. 2003;2(2):104–113.Google ScholarPubMed
3.DuPaul, GJ, Power, TJ, Anastopoulos, AD, Reid, R. ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretation. New York, NY: Guilford Press. 1998.Google Scholar
4.Swanson, J, Lerner, M, March, J, Gresham, FM. Assessment and intervention for attention-deficit/hyperactivity disorder in the schools. Lessons from the MTA study. Pediatr Clin North Am. 1999;46(5):993–1009.CrossRefGoogle ScholarPubMed
5.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(2):168–179.CrossRefGoogle ScholarPubMed
6.Steele, M, Jensen, PS, Quinn, DMP. Remission versus response as the goal of therapy in ADHD: a new standard for the field? Clin Ther. 2006;28(11):1892–1908.Google Scholar
7.Frank, E, Prien, RF, Jarrett, RB, et al. Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence. Arch Gen Psychiatry. 1991;48(9):851–855.CrossRefGoogle ScholarPubMed
8.Paykel, ES, Ramana, R, Cooper, Z, Hayhurst, H, Kerr, J, Barocka, A. Residual symptoms after partial remission: an important outcome in depression. Psychol Med. 1995;25(6):1171–1180.Google Scholar
9.Miller, IW, Keitner, GI, Schatzberg, AF, et al. The treatment of chronic depression, part 3: psychosocial functioning before and after treatment with sertraline or imipramine. J Clin Psychiatry. 1998;59(11):608–619.Google Scholar
10.Simon, GE, Revicki, D, Heiligenstein, J, et al. Recovery from depression, work productivity, and health care costs among primary care patients. Gen Hosp Psychiatry. 2000;22(3):153–162.Google Scholar
11.Tohen, M, Frank, E, Bowden, CL, et al. The International Society for Bipolar Disorders (ISBD) Task Force report on the nomenclature of course and outcome in bipolar disorders. Bipolar Disord. 2009;11(5):453–473.Google Scholar
12.Leucht, S, Davis, JM, Engel, RR, Kissling, W, Kane, JM. Definitions of response and remission in schizophrenia: recommendations for their use and their presentation. Acta Psychiatr Scand Suppl. 2009;119(suppl 438):7–14.Google Scholar
13.Biederman, J, Mick, E, Faraone, SV. Age-dependent decline of symptoms of attention deficit hyperactivity disorder: impact of remission definition and symptom type. Am J Psychiatry. 2000;157(5):816–818.CrossRefGoogle ScholarPubMed
14.Stein, MA, Sarampote, CS, Waldman, ID, et al. A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics. 2003;112(5):e404.CrossRefGoogle ScholarPubMed
15.Biederman, J, Krishnan, S, Zhang, Y, McGough, JJ, Findling, RL. 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.CrossRefGoogle ScholarPubMed
16.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.CrossRefGoogle ScholarPubMed
17.Wigal, SB, Kollins, SH, Childress, AC, Squires, L, for the 311 Study Group. A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. Child Adolesc Psychiatry Mentl Health. 2009;3(1):17.CrossRefGoogle ScholarPubMed
18.Findling, RL, Childress, AC, Krishnan, S, McGough, JJ. Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. CNS Spectr. 2008;13(7):614–620.Google Scholar
19. Attention-deficit and disruptive behavior disorders. In: Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Text Rev. Washington, DC: American Psychiatric Association; 2000:85–93.Google Scholar
20.Guy, W. Clinical global impressions. In: ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare; Public Health Service, Alcohol, Drug Abuse and Mental Health Administration, NIMH Psychopharmacology Research Branch; 1976;218–222.Google Scholar
21.Michelson, D, Allen, AJ, Busner, J, et al. Once-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized, placebo-controlled study. Am J Psychiatry. 2002;159(11):1896–1901.CrossRefGoogle ScholarPubMed
22.Kelsey, DK, Sumner, CR, Casat, CD, et al. Once-daily atomoxetine treatment for children with attention-deficit/hyperactivity disorder, including an assessment of evening and morning behavior: a double-blind, placebo-controlled trial. Pediatrics. 2004;114(1):e1–e8.CrossRefGoogle ScholarPubMed
23.Spencer, T, Heiligenstein, JH, Biederman, J, et al. Results from 2 proof-of-concept, placebo controlled studies of atomoxetine in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2002;63(12):1140–1147.Google Scholar
24.Spencer, T, Biederman, J, Wilens, T, et al. Efficacy of a mixed amphetamine salts compound in adults with attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 2001;58(8):775–782.CrossRefGoogle ScholarPubMed
25.Kemner, JE, Starr, HL, Ciccone, PE, Hooper-Wood, CG, Crockett, RS. Outcomes of OROS® methylphenidate compared with atomoxetine in children with ADHD: a multicenter, randomized prospective study. Adv Ther. 2005;22(5):498–512.CrossRefGoogle ScholarPubMed
26.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/hyperactivity disorder. J Atten Disord. 2005;9(1):275–289.Google Scholar
27.Greenhill, L, Wan, G, Cooper, K. Remission of ADHD symptoms with stimulant therapy. Poster presented at: the 157th Annual Meeting of the American Psychiatric Association; May 1-6, 2004; Washington DC.Google Scholar
28.Steele, M, Weiss, M, Swanson, J, Wang, J, Prinzo, RS, Binder, CE. A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate release methylphenidate in attention deficit-hyperactivity disorder. Can J Clin Pharmacol. 2006;13(1):e50–e62.Google Scholar
29.MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Multimodal Treatment Study of Children with ADHD. Arch Gen Psychiatry. 1999;56(12):1073–1086.CrossRefGoogle Scholar
30.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.CrossRefGoogle ScholarPubMed
31.Efron, D, Jarman, F, Barker, M. Methylphenidate versus dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial. Pediatrics. 1997;100(6):E6.CrossRefGoogle ScholarPubMed
32.Ahmann, PA, Theye, FW, Berg, R, Linquist, AJ, Van Erem, AJ, Campbell, LR. Placebo-controlled evaluation of amphetamine mixture–dextroamphetamine salts and amphetamine salts (Adderall): efficacy rate and side effects. Pediatrics. 2001;107(1):E10.Google Scholar
33.Weiss, M, Tannock, R, Kratochvil, C, et al. A randomized, placebo-controlled study of once daily atomoxetine in the school setting in children with ADHD. J Am Acad Child Adolesc Psychiatry. 2005;44(7):647–655.CrossRefGoogle ScholarPubMed
34.Goodman, D, Faraone, SV, Adler, LA, Dirks, B, Hamdani, M, Weisler, R. Interpreting ADHD Rating Scale scores: linking ADHD rating scale scores and CGI levels in two randomized controlled trials of lisdexamfetamine dimesylate in ADHD. Primary Psychiatry. 2010;17(3):44–52.Google Scholar
35.Molina, BS, Hinshaw, SP, Swanson, JM, et al. The MTA at 8 years: prospective follow-up of children treated for combined-type ADHD in a multisite study. J Am Acad Child Adolesc Psychiatry. 2009;48(5):484–500.CrossRefGoogle Scholar
36.Epstein, JN, Langberg, JM, Lichtenstein, PK, et al. Attention-deficit/hyperactivity disorder outcomes for children treated in community-based pediatric settings. Arch Pediatr Adolesc Med. 2010;164(2):160–165.CrossRefGoogle ScholarPubMed
37.Biederman, J, Monuteaux, MC, Spencer, T, Wilens, TE, Faraone, SV. Do stimulants protect against psychiatric disorders in youth with ADHD? A 10-year follow-up study. Pediatrics. 2009;124(1):71–78.Google Scholar