title: Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Psychiatry and Biobehavioral Sciences, Division of Child andAdolescent Psychiatry, UCLA Neuropsychiatric Institute, Los Angeles, CA 90024-1759, USA. jmccracken@mednet.ucla.edu
authors.forename: James T
authors.initials: JT
authors.lastname: McCracken
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
authors.forename: Laurence L
authors.initials: LL
authors.lastname: Greenhill
authors.forename: James M
authors.initials: JM
authors.lastname: Swanson
authors.forename: James J
authors.initials: JJ
authors.lastname: McGough
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Spencer
authors.forename: Kelly
authors.initials: K
authors.lastname: Posner
authors.forename: Sharon
authors.initials: S
authors.lastname: Wigal
authors.forename: Caroly
authors.initials: C
authors.lastname: Pataki
authors.forename: Yuxin
authors.initials: Y
authors.lastname: Zhang
authors.forename: Simon
authors.initials: S
authors.lastname: Tulloch
mesh_terms: D000662:Amphetamines / Q000494:pharmacology* / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D012574:Schools; D013995:Time
chemical_list: D000662:Amphetamines; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; C449521:SLI381