Lisdexamfetamine Dimesylate and Mixed Amphetamine Salts Extended-Release in Children with ADHD: A Double-Blind, Placebo-Controlled, Crossover Analog Classroom Study

Joseph Biederman, Samuel W. Boellner, Ann Childress, Frank A. Lopez, Suma Krishnan, Yuxin Zhang

Research output: Contribution to journalArticlepeer-review

156 Scopus citations

Abstract

Background: Lisdexamfetamine dimesylate is a therapeutically inactive prodrug in which d-amphetamine is covalently bound to l-lysine, a naturally occurring amino acid. Pharmacologically active d-amphetamine is released from lisdexamfetamine following oral ingestion. Methods: This phase 2, randomized, double-blind, placebo- and active-controlled crossover study compared the efficacy and safety of lisdexamfetamine (LDX: 30, 50, or 70 mg) with placebo, with mixed amphetamine salts extended-release (MAS XR: 10, 20, or 30 mg) included as a reference arm of the study, in 52 children aged 6 to 12 years with attention-deficit/hyperactivity disorder (ADHD) in an analog classroom setting. The primary efficacy measure was the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale; secondary efficacy measures included the Permanent Product Measure of Performance (PERMP) Derived Measures, and the Clinical Global Impression (CGI) Scale. Results: LDX treatment significantly improved scores on SKAMP-deportment, SKAMP-attention, PERMP-attempted, PERMP-correct, and CGI-improvement from baseline. Adverse events were similar for both active treatments. Conclusions: In a laboratory classroom environment, LDX significantly improved ADHD symptoms versus placebo in school-age children with ADHD.

Original languageEnglish
Pages (from-to)970-976
Number of pages7
JournalBiological Psychiatry
Volume62
Issue number9
DOIs
StatePublished - 1 Nov 2007
Externally publishedYes

Keywords

  • ADHD
  • amphetamine
  • analog classroom
  • double blind
  • lisdexamfetamine
  • mixed amphetamine salts

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