PMID- 24297663
OWN - NLM
STAT- MEDLINE
DCOM- 20140915
LR  - 20211021
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Print)
IS  - 1173-2563 (Linking)
VI  - 34
IP  - 2
DP  - 2014 Feb
TI  - Randomized, double-blind, placebo-controlled, crossover study of the effects of 
      lisdexamfetamine dimesylate and mixed amphetamine salts on cognition throughout 
      the day in adults with attention-deficit/hyperactivity disorder.
PG  - 147-57
LID - 10.1007/s40261-013-0156-z [doi]
AB  - BACKGROUND: Understanding the nature and time course of the pharmacodynamic 
      effects of attention-deficit/hyperactivity disorder (ADHD) medications is useful. 
      The Cognitive Drug Research Computerized Battery of Tests (CDR-CBT) is a 20-min 
      battery of ten standardized, validated neuropsychometric tasks. OBJECTIVE: This 
      pilot study examined the sensitivity and responsiveness of the CDR-CBT for 
      assessing cognitive function in adults with ADHD prior to and up to 16 h postdose 
      during treatment with lisdexamfetamine dimesylate (LDX) or mixed amphetamine 
      salts immediate release (MAS-IR; various generics available). METHODS: This was a 
      double-blind three-period crossover study. Participants received LDX 50 mg/day, 
      MAS-IR 20 mg/day, and placebo (~7 a.m.) for 7 days each in randomized order. 
      CDR-CBT was administered on day 1 of period 1 and day 7 of each period at 
      scheduled times between -0.5 (predose) and 16 h postdose. Composite power of 
      attention (PoA) score (sum of simple reaction time, choice reaction time, and 
      digit vigilance speed) was the primary outcome measure. The Conners' Adult ADHD 
      Rating Scales-Self-Report: Short Version (CAARS-S:S) was administered at baseline 
      and on day 1 of period 1, and days 6 and 7 of each treatment period. Tertiary 
      outcomes included CDR-CBT composite continuity of attention scores, its component 
      task scores, cognitive reaction time, and response variability scores. No 
      inferential statistical comparisons were conducted. Safety assessments included 
      adverse events (AEs) and vital signs. RESULTS: This analysis included 18 
      participants (mean age 30.8 years); one withdrew because of AEs. Mean 
      pretreatment PoA scores were 1175.9-1361.2 ms, scores commensurate with a 
      normative age of >40 years. Maximum reductions in PoA scores with LDX and MAS-IR 
      occurred at 5 h postdose at day 7 (least squares mean difference [95% CI] of 
      -150.0 [-235.41 to -64.50] and -79.8 [-165.72 to 6.21] ms vs. placebo, 
      respectively). CAARS-S:S scores were unchanged with LDX and MAS-IR (vs. placebo) 
      at all postdose timepoints. Tertiary attention-related CDR-CBT outcomes were 
      sensitive to LDX and MAS-IR (vs. placebo). Treatment-emergent AEs and vital signs 
      were consistent with previous studies in adult ADHD. CONCLUSION: In adults with 
      ADHD, PoA scores indicated impaired attention at baseline and response to 
      treatment with LDX and MAS-IR (vs. placebo), demonstrating value for measuring 
      the time course of pharmacologic treatment effects.
FAU - Martin, Patrick T
AU  - Martin PT
AD  - Shire Development LLC, 725 Chesterbrook Blvd, Wayne, PA, 19087-5637, USA, 
      pmartin@shire.com.
FAU - Corcoran, Mary
AU  - Corcoran M
FAU - Zhang, Pinggao
AU  - Zhang P
FAU - Katic, Alain
AU  - Katic A
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Amphetamines)
RN  - 0 (Central Nervous System Stimulants)
RN  - SJT761GEGS (Lisdexamfetamine Dimesylate)
RN  - TZ47U051FI (Dextroamphetamine)
SB  - IM
MH  - Adult
MH  - Amphetamines/administration & dosage/*therapeutic use
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Central Nervous System Stimulants/administration & dosage/therapeutic use
MH  - Cognition/*drug effects
MH  - Cross-Over Studies
MH  - Dextroamphetamine/administration & dosage/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Lisdexamfetamine Dimesylate
MH  - Male
MH  - Neuropsychological Tests
MH  - Pilot Projects
MH  - Psychometrics
MH  - Reaction Time/drug effects
MH  - Sensitivity and Specificity
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC3899471
EDAT- 2013/12/04 06:00
MHDA- 2014/09/16 06:00
PMCR- 2013/12/03
CRDT- 2013/12/04 06:00
PHST- 2013/12/04 06:00 [entrez]
PHST- 2013/12/04 06:00 [pubmed]
PHST- 2014/09/16 06:00 [medline]
PHST- 2013/12/03 00:00 [pmc-release]
AID - 156 [pii]
AID - 10.1007/s40261-013-0156-z [doi]
PST - ppublish
SO  - Clin Drug Investig. 2014 Feb;34(2):147-57. doi: 10.1007/s40261-013-0156-z.