TY - JOUR
T1 - Lisdexamfetamine Dimesylate and Mixed Amphetamine Salts Extended-Release in Children with ADHD
T2 - A Double-Blind, Placebo-Controlled, Crossover Analog Classroom Study
AU - Biederman, Joseph
AU - Boellner, Samuel W.
AU - Childress, Ann
AU - Lopez, Frank A.
AU - Krishnan, Suma
AU - Zhang, Yuxin
N1 - Funding Information:
Joseph Biederman, MD, receives or received research support from, is or has been a speaker for, or is or has been on the advisory board for the following pharmaceutical companies: Shire, Eli Lilly, Pfizer, McNeil, Abbott, Bristol-Myers Squibb, New River Pharmaceuticals, Cephalon, Janssen, Novartis, UCB Pharma, AstraZeneca, Forest Laboratories, GlaxoSmithKline, and Neurosearch. Dr. Biederman has also received research support from Stanley Medical Institute, Inc.; Lilly Foundation; Prechter Foundation; National Institute of Mental Health; National Institute of Child Health and Human Development, and National Institute on Drug Abuse. Samuel W. Boellner, MD, is a consultant for Cephalon and has served as an investigator for CellTech, Cephalon, New River Pharmaceuticals, Novartis, and Shire. Ann Childress, MD, is a consultant and on the speakers bureaus for Novartis and Shire. Frank A. López, MD, is a consultant for Eli Lilly and New River Pharmaceuticals; receives research support from Cephalon, Eli Lilly, New River Pharmaceuticals, Novartis Noven, and Shire; and is on the speakers bureaus for Cephalon, Novartis, Shire, and Shire-Biochem Canada. Suma Krishnan, MS, is a full-time employee of New River Pharmaceuticals. Yuxin Zhang, PhD, is a consultant for New River Pharmaceuticals.
Funding Information:
This study was supported by New River Pharmaceuticals Inc. and Shire Development Inc.
PY - 2007/11/1
Y1 - 2007/11/1
N2 - 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.
AB - 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.
KW - ADHD
KW - amphetamine
KW - analog classroom
KW - double blind
KW - lisdexamfetamine
KW - mixed amphetamine salts
UR - http://www.scopus.com/inward/record.url?scp=34948906993&partnerID=8YFLogxK
U2 - 10.1016/j.biopsych.2007.04.015
DO - 10.1016/j.biopsych.2007.04.015
M3 - Article
C2 - 17631866
AN - SCOPUS:34948906993
SN - 0006-3223
VL - 62
SP - 970
EP - 976
JO - Biological Psychiatry
JF - Biological Psychiatry
IS - 9
ER -