PMID- 19508731
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20100520
LR  - 20211020
IS  - 1753-2000 (Electronic)
IS  - 1753-2000 (Linking)
VI  - 3
IP  - 1
DP  - 2009 Jun 9
TI  - A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged 
      children with attention-deficit/hyperactivity disorder.
PG  - 17
LID - 10.1186/1753-2000-3-17 [doi]
AB  - BACKGROUND: Lisdexamfetamine dimesylate (LDX) is indicated for the treatment of 
      attention-deficit/hyperactivity disorder (ADHD) in children 6 to 12 years of age 
      and in adults. In a previous laboratory school study, LDX demonstrated efficacy 2 
      hours postdose with duration of efficacy through 12 hours. The current study 
      further characterizes the time course of effect of LDX. METHODS: Children aged 6 
      to 12 years with ADHD were enrolled in a laboratory school study. The multicenter 
      study consisted of open-label, dose-optimization of LDX (30, 50, 70 mg/d, 4 
      weeks) followed by a randomized, placebo-controlled, 2-way crossover phase (1 
      week each). Efficacy measures included the SKAMP (deportment [primary] and 
      attention [secondary]) and PERMP (attempted/correct) scales (secondary) measured 
      at predose and at 1.5, 2.5, 5, 7.5, 10, 12, and 13 hours postdose. Safety 
      measures included treatment-emergent adverse events (AEs), physical examination, 
      vital signs, and ECGs. RESULTS: A total of 117 subjects were randomized and 111 
      completed the study. Compared with placebo, LDX demonstrated significantly 
      greater efficacy at each postdose time point (1.5 hours to 13.0 hours), as 
      measured by SKAMP deportment and attention scales and PERMP (P < .005). The most 
      common treatment-emergent AEs during dose optimization were decreased appetite 
      (47%), insomnia (27%), headache (17%), irritability (16%), upper abdominal pain 
      (16%), and affect lability (10%), which were less frequent in the crossover phase 
      (6%, 4%, 5%, 1%, 2%, and 0% respectively). CONCLUSION: In school-aged children (6 
      to 12 years) with ADHD, efficacy of LDX was maintained from the first time point 
      (1.5 hours) up to the last time point assessed (13.0 hours). LDX was generally 
      well tolerated, resulting in typical stimulant AEs. TRIAL REGISTRATION: Official 
      Title: A Phase IIIb, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, 
      Dose-Optimization, Cross-Over, Analog Classroom Study to Assess the Time of Onset 
      of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With 
      Attention-Deficit/Hyperactivity Disorder. ClinicalTrials.gov Identifier: 
      NCT00500149 http://clinicaltrials.gov/ct2/show/NCT00500149.
FAU - Wigal, Sharon B
AU  - Wigal SB
AD  - University of California, Irvine, Child Development Center, Irvine, California, 
      USA. sbwigal@uci.edu
FAU - Kollins, Scott H
AU  - Kollins SH
FAU - Childress, Ann C
AU  - Childress AC
FAU - Squires, Liza
AU  - Squires L
CN  - 311 Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00500149
PT  - Journal Article
DEP - 20090609
PL  - England
TA  - Child Adolesc Psychiatry Ment Health
JT  - Child and adolescent psychiatry and mental health
JID - 101297974
PMC - PMC2704174
FIR - Brams, Matthew
IR  - Brams M
FIR - Childress, Ann
IR  - Childress A
FIR - Kollins, Scott H
IR  - Kollins SH
FIR - Lerner, Marc A
IR  - Lerner MA
FIR - Moon, Eliot
IR  - Moon E
FIR - Turnbow, John M
IR  - Turnbow JM
FIR - Vince, Bradley
IR  - Vince B
FIR - Wigal, Sharon B
IR  - Wigal SB
EDAT- 2009/06/11 09:00
MHDA- 2009/06/11 09:01
PMCR- 2009/06/09
CRDT- 2009/06/11 09:00
PHST- 2009/02/11 00:00 [received]
PHST- 2009/06/09 00:00 [accepted]
PHST- 2009/06/11 09:00 [entrez]
PHST- 2009/06/11 09:00 [pubmed]
PHST- 2009/06/11 09:01 [medline]
PHST- 2009/06/09 00:00 [pmc-release]
AID - 1753-2000-3-17 [pii]
AID - 10.1186/1753-2000-3-17 [doi]
PST - epublish
SO  - Child Adolesc Psychiatry Ment Health. 2009 Jun 9;3(1):17. doi: 
      10.1186/1753-2000-3-17.