PMID- 33395356
OWN - NLM
STAT- MEDLINE
DCOM- 20211022
LR  - 20211022
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 31
IP  - 3
DP  - 2021 Apr
TI  - A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Clinical Trial 
      of ORADUR-Methylphenidate for Treating Children and Adolescents with 
      Attention-Deficit/Hyperactivity Disorder.
PG  - 164-178
LID - 10.1089/cap.2020.0104 [doi]
AB  - Objective: Methylphenidate (MPH) is efficacious in reducing symptoms of 
      attention-deficit/hyperactivity disorder (ADHD), but there are no data about the 
      efficacy and safety of its new formulation (ORADUR((R))-MPH extended release, 
      ORADUR-MPH) in patients with ADHD, which is the study objective. Method: This was 
      a Phase III, multicenter, randomized, double-blind, placebo-controlled, two-way 
      crossover clinical trial. One hundred children and adolescents with a clinical 
      diagnosis of ADHD (72.7% male) received at least one dose of ORADUR-MPH or a 
      placebo during the 2-week treatment period of each phase. The primary efficacy 
      measure was the Swanson, Nolan, and Pelham-IV-teacher (SNAP-IV-T) form. Secondary 
      efficacy measures included the SNAP-IV-parent form, the Clinical Global 
      Impression: ADHD-Severity score, the Conner's Teacher's Rating Scale score, and 
      the investigator's rating for 18 Diagnostic and Statistical Manual of Mental 
      Disorders, 5th edition ADHD symptoms. In addition, data related to vital signs, 
      body weight, physical examination, laboratory testing, and adverse events (AEs) 
      were also collected. All data were analyzed on an intent-to-treat basis. Results: 
      Without adjusting for differences in demographics and baseline measures, both 
      treatment groups showed significant reductions in ADHD and oppositional defiant 
      disorder symptoms after a 2-week treatment with greater effect sizes (Cohen's d) 
      in the ORADUR-MPH group (Cohen's d ranging from -0.41 to -1.64; placebo, Cohen's 
      d ranging from -0.26 to -1.18), except for oppositional symptoms, regardless of 
      the informants. For the primary efficacy measure, ORADUR-MPH was significantly 
      superior to the placebo, as evidenced by lower values for and greater reductions 
      in the SNAP-IV-T scores at the endpoint (Cohen's d = -0.16, p = 0.005) and from 
      baseline to the endpoint (Cohen's d = -0.19, p = 0.006), respectively. There were 
      no serious AEs during the clinical study period. The most frequently observed AE 
      was decreased appetite (49.1%). Most physical and laboratory test variables 
      remained within the normal range. Conclusions: Once-daily ORADUR-MPH is an 
      effective, well-tolerable, and safe treatment for children and adolescents with 
      ADHD. ClinicalTrials.gov number, NCT02450890.
FAU - Huang, Yu-Shu
AU  - Huang YS
AD  - Department of Child Psychiatry, Chang Gung Memorial Hospital and University, 
      Taoyuan, Taiwan.
FAU - Yeh, Chin-Bin
AU  - Yeh CB
AD  - Department of Psychiatry, Tri-Service General Hospital and University, Taipei, 
      Taiwan.
FAU - Chen, Chin-Hung
AU  - Chen CH
AD  - Department of Psychiatry, Chang Gung Memorial Hospital and University, Chiayi, 
      Taiwan.
FAU - Shang, Chi-Yung
AU  - Shang CY
AD  - Department of Psychiatry, National Taiwan University Hospital and College of 
      Medicine, National Taiwan University, Taipei, Taiwan.
FAU - Gau, Susan Shur-Fen
AU  - Gau SS
AD  - Department of Psychiatry, National Taiwan University Hospital and College of 
      Medicine, National Taiwan University, Taipei, Taiwan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02450890
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201231
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Delayed-Action Preparations)
RN  - 207ZZ9QZ49 (Methylphenidate)
SB  - IM
MH  - Adolescent
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Body Weight
MH  - Central Nervous System Stimulants/*therapeutic use
MH  - Child
MH  - Cross-Over Studies
MH  - *Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Methylphenidate/*therapeutic use
MH  - Treatment Outcome
PMC - PMC8066345
OTO - NOTNLM
OT  - ORADUR-methylphenidate
OT  - attention-deficit/hyperactivity disorder
OT  - children
OT  - efficacy
OT  - safety
COIS- No competing financial interests exist.
EDAT- 2021/01/05 06:00
MHDA- 2023/02/25 06:00
PMCR- 2021/04/16
CRDT- 2021/01/04 17:07
PHST- 2021/01/05 06:00 [pubmed]
PHST- 2023/02/25 06:00 [medline]
PHST- 2021/01/04 17:07 [entrez]
PHST- 2021/04/16 00:00 [pmc-release]
AID - 10.1089/cap.2020.0104 [pii]
AID - 10.1089/cap.2020.0104 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2021 Apr;31(3):164-178. doi: 
      10.1089/cap.2020.0104. Epub 2020 Dec 31.