Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study.
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.
Biederman
Joseph
J
Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA. biederman@helix.mgh.harvard.edu
Boellner
Samuel W
SW
Childress
Ann
A
Lopez
Frank A
FA
Krishnan
Suma
S
Zhang
Yuxin
Y
D000661:Amphetamine / 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 / Q000627:therapeutic use; D003913:Dextroamphetamine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D011569:Psychiatric Status Rating Scales; D013997:Time Factors; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D000661:Amphetamine; D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine