PMID- 22926597
OWN - NLM
STAT- MEDLINE
DCOM- 20130116
LR  - 20151119
IS  - 1533-712X (Electronic)
IS  - 0271-0749 (Linking)
VI  - 32
IP  - 5
DP  - 2012 Oct
TI  - A randomized, double-blind study of 30 versus 20 mg dexmethylphenidate 
      extended-release in children with attention-deficit/hyperactivity disorder: 
      late-day symptom control.
PG  - 637-44
LID - 10.1097/JCP.0b013e3182677825 [doi]
AB  - The objective of this study was to evaluate the safety and efficacy of 
      dexmethylphenidate extended-release (d-MPH-ER) 30 versus 20 mg in children with 
      attention-deficit/hyperactivity disorder (ADHD) in a 12-hour laboratory classroom 
      setting. In a randomized, double-blind, 3-period x 3-treatment, crossover study, 
      children aged 6 to 12 years with Diagnostic and Statistical Manual of Mental 
      Disorders, Fourth Edition-diagnosed ADHD previously stabilized on MPH (40-60 
      mg/d) or D-MPH (20-30 mg/day) [corrected] were randomized to receive D-MPH-ER 20 
      mg/day, 30 mg/day, [corrected] or placebo for 7 days each. Primary efficacy 
      measurements were change in the average SKAMP-Combined [corrected] score from 
      predose to 10, 11, and 12 hours postdose [Avg(10-12)] between 30 mg [corrected] 
      and 20 mg D-MPH-ER. Safety was assessed by adverse events, (AEs), [corrected] 
      vital sign monitoring, and ECGs. [corrected] A total of 165 children were 
      randomized, and 162 included in the intent-to-treat analysis. Mean Avg (10-12) 
      change from pre-dose [corrected] in SKAMP-Combined score was significantly 
      greater for D-MPH-ER 30 mg (-4.47) compared with D-MPH-ER 20 mg (-2.02; P = 
      0.002). Most common adverse events (>/= 3% in any group) were decreased appetite 
      (6.1%, 4.9%, and 0%), headache (4.3%, 4.3%, and 1.9%), abdominal pain (3.7%, 
      3.1%, and 3.1%), and tachycardia (1.2%, 3.1%, and 0.6%) for D-MPH-ER 30 mg, 
      D-MPH-ER 20 mg, and placebo, respectively). Significantly greater improvement in 
      ADHD symptoms was noted with D-MPH-ER 30 mg compared with D-MPH-ER 20 mg at hours 
      10 through 12. Tolerability was comparable between doses. Dexmethylphenidate 
      extended-release 30-mg dose may provide further benefit to patients who do not 
      maintain optimal symptom control later in the day with D-MPH-ER 20 mg.
FAU - Brams, Matthew
AU  - Brams M
AD  - Menninger Department of Psychiatry, Baylor College of Medicine, Houston, TX 
      77007, USA. drmattbrams@aol.com
FAU - Turnbow, John
AU  - Turnbow J
FAU - Pestreich, Linda
AU  - Pestreich L
FAU - Giblin, John
AU  - Giblin J
FAU - Childress, Ann
AU  - Childress A
FAU - McCague, Kevin
AU  - McCague K
FAU - Muniz, Rafael
AU  - Muniz R
LA  - eng
SI  - ClinicalTrials.gov/NCT00776009
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychopharmacol
JT  - Journal of clinical psychopharmacology
JID - 8109496
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Delayed-Action Preparations)
RN  - 1678OK0E08 (Dexmethylphenidate Hydrochloride)
RN  - 207ZZ9QZ49 (Methylphenidate)
SB  - IM
EIN - J Clin Psychopharmacol. 2012 Dec;32(6):766
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy/physiopathology
MH  - Central Nervous System Stimulants/*administration & dosage/adverse effects
MH  - Child
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations
MH  - *Dexmethylphenidate Hydrochloride
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Methylphenidate/*administration & dosage/adverse effects
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2012/08/29 06:00
MHDA- 2013/01/17 06:00
CRDT- 2012/08/29 06:00
PHST- 2012/08/29 06:00 [entrez]
PHST- 2012/08/29 06:00 [pubmed]
PHST- 2013/01/17 06:00 [medline]
AID - 10.1097/JCP.0b013e3182677825 [doi]
PST - ppublish
SO  - J Clin Psychopharmacol. 2012 Oct;32(5):637-44. doi: 10.1097/JCP.0b013e3182677825.