Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD.
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.
McCracken
James T
JT
Department of Psychiatry and Biobehavioral Sciences, Division of Child andAdolescent Psychiatry, UCLA Neuropsychiatric Institute, Los Angeles, CA 90024-1759, USA. jmccracken@mednet.ucla.edu
Biederman
Joseph
J
Greenhill
Laurence L
LL
Swanson
James M
JM
McGough
James J
JJ
Spencer
Thomas J
TJ
Posner
Kelly
K
Wigal
Sharon
S
Pataki
Caroly
C
Zhang
Yuxin
Y
Tulloch
Simon
S
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
D000662:Amphetamines; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; C449521:SLI381