Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (ADDERALL XR), in children with ADHD

James T. McCracken, Joseph Biederman, Laurence L. Greenhill, James M. Swanson, James J. McGough, Thomas J. Spencer, Kelly Posner, Sharon Wigal, Caroly Pataki, Yuxin Zhang, Simon Tulloch

Research output: Contribution to journalArticlepeer-review

101 Scopus citations

Abstract

Objectives: This investigation was conducted primarily to assess the safety and efficacy of SLI381 (Adderall XR™), developed as a once-daily treatment for children with attention-deficit/hyperactivity disorder (ADHD). Secondary objectives included examination of the time course, pharmacokinetic, and pharmacodynamic properties of SLI381. Method: This was a randomized, double-blind, crossover study of three doses of SLI381 (10, 20, and 30 mg), placebo, and an active control (Adderall® 10 mg) given once daily to 51 children with ADHD. Weekly assessments in an analog classroom setting included blind ratings of attention and deportment and a performance measure (math test) obtained every 1.5 hours over a 12-hour period. Results: SLI381 was well tolerated. All active treatment conditions displayed significant time course effects and were superior to placebo in improving efficacy measures. Dose-dependent improvements were evident for SLI381. SLI381 20 and 30 mg and Adderall all showed rapid improvements by 1.5 hours, but only the SLI381 20- and 30-mg doses showed continued activity at 10.5 and 12 hours for classroom behavior and math test performance versus placebo. Conclusions: These data provide support for the benefit of this novel, once-daily amphetamine preparation in the treatment of ADHD. The longer duration of action of SLI381 has the potential to simplify psychostimulant dosing, thus reducing dose diversion and eliminating the need for in-school administration. SLI381 appears to be a useful treatment option for many children with ADHD.

Original languageEnglish
Pages (from-to)673-683
Number of pages11
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume42
Issue number6
DOIs
StatePublished - Jun 2003
Externally publishedYes

Keywords

  • ADDERALL XR™
  • Adderall®
  • Amphetamine
  • Attention-deficit/hyperactivity disorder
  • Children
  • Stimulant

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