Clinical response and symptomatic remission in children treated with lisdexamfetamine dimesylate for attention-deficit/hyperactivity disorder

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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)559-568
Number of pages10
JournalCNS Spectrums
Volume15
Issue number9
StatePublished - Sep 2010
Externally publishedYes

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Attention Deficit Disorder with Hyperactivity
Placebos
Lisdexamfetamine Dimesylate

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health

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Clinical response and symptomatic remission in children treated with lisdexamfetamine dimesylate for attention-deficit/hyperactivity disorder. / Findling, Robert L; Adeyi, Ben; Chen, Gary; Dirks, Bryan; Babcock, Thomas; Scheckner, Brian; Pharm, D.; Lasser, Robert; Pucci, Michael L.; Abdullah, Huda I.; McGough, James J.

In: CNS Spectrums, Vol. 15, No. 9, 09.2010, p. 559-568.

Research output: Contribution to journalArticle

Findling, RL, Adeyi, B, Chen, G, Dirks, B, Babcock, T, Scheckner, B, Pharm, D, Lasser, R, Pucci, ML, Abdullah, HI & McGough, JJ 2010, 'Clinical response and symptomatic remission in children treated with lisdexamfetamine dimesylate for attention-deficit/hyperactivity disorder', CNS Spectrums, vol. 15, no. 9, pp. 559-568.
Findling, Robert L ; Adeyi, Ben ; Chen, Gary ; Dirks, Bryan ; Babcock, Thomas ; Scheckner, Brian ; Pharm, D. ; Lasser, Robert ; Pucci, Michael L. ; Abdullah, Huda I. ; McGough, James J. / Clinical response and symptomatic remission in children treated with lisdexamfetamine dimesylate for attention-deficit/hyperactivity disorder. In: CNS Spectrums. 2010 ; Vol. 15, No. 9. pp. 559-568.
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