title: Efficacy, Safety, and Tolerability of a Novel Methylphenidate Extended-Release Oral Suspension (MEROS) in ADHD.
abstract: OBJECTIVE
  To test whether an optimal dose of Quillivant XR (methylphenidate extended-release oral suspension [MEROS]) would significantly reduce symptoms of ADHD in children.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled, cross-over, efficacy, safety, and tolerability study of MEROS in 45 children aged 6 to 12 years (open-label dose-optimization phase, followed by double-blind cross-over period).
  
  
  RESULTS
  MEROS was significantly more efficacious than placebo during double-blind cross-over laboratory classroom days (Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale and Permanent Product Measure of Performance). During the open-label phase, improvements were observed in scores of ADHD Rating Scale-IV, and Clinical Global Impression-Severity and -Improvement Scales. No occurrences of suicidal ideation or behavior were recorded; the most common open-label treatment-emergent adverse events were typical of stimulant use: decreased appetite, insomnia, and abdominal pain.
  
  
  CONCLUSIONS
  MEROS was efficacious in the treatment of children aged 6 to 12 years with ADHD, with a safety profile similar to that of other extended-release methylphenidate pharmacotherapies.
authors.affiliation: 1 George Washington University, Washington, DC, USA.
authors.forename: Adelaide S
authors.initials: AS
authors.lastname: Robb
authors.affiliation: 2 Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.affiliation: 3 Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.
authors.forename: Ann C
authors.initials: AC
authors.lastname: Childress
authors.affiliation: 4 Pfizer Inc., New York, NY, USA.
authors.forename: Sally A
authors.initials: SA
authors.lastname: Berry
authors.affiliation: 4 Pfizer Inc., New York, NY, USA.
authors.forename: Heidi W
authors.initials: HW
authors.lastname: Belden
authors.affiliation: 5 AVIDA Inc, Newport Beach, CA, USA.
authors.forename: Sharon B
authors.initials: SB
authors.lastname: Wigal
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D007319:Sleep Initiation and Maintenance Disorders; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate
keywords: ADHD; laboratory school; math test; methylphenidate; randomized-controlled trial