None of the mediators or moderators tested affected methylpheni date efficacy .
Academic improvements were small compared to symptom improvements ; qualitative changes limited to math .
Academic improvement is amongst the most common treatment targets when prescribing stimulants to children with ADHD .
Previous review s on stimulant-related academic improvements are inconclusive and focus on task engagement .
Recent literature suggests outcome -domain-specific medication effects that are larger for productivity than for accuracy .
The aims of this study are quantifying methylpheni date effects on academic productivity and accuracy for math , reading , spelling ; exploring the mediating or moderating effects of symptom improvements , demographic- , design - and disorder-related variables .
Pharmacokinetics and therapeutic effect of OROS methylphenidate under different breakfast conditions in children with attention-deficit/hyperactivity disorder.
OBJECTIVE To examine the pharmacokinetics ( PKs ) and pharmacodynamics ( PDs ) of OROS methylpheni date ( OROS MPH ) dosed once daily ( QD ) versus an early st and ard regimen ( immediate-release [ IR ] MPH dosed three times daily [ TID ] ) under various breakfast conditions . METHODS This single-center , double-blind , double-dummy , r and omized , crossover study of OROS MPH ( NCT00269815 ) in children aged 6 to 12 years with attention-deficit/hyperactivity disorder evaluated the PKs and PDs of MPH given with different breakfast conditions : OROS MPH administered after a high-fat breakfast , after a normal breakfast , or after fasting and IR MPH administered after a normal breakfast or after fasting in the morning and at two subsequent time points during the day . To maximize information , patients were divided into two groups , each receiving three of the five treatments for 1 day in a three-period , r and omized , crossover design . Patients were assigned to 1 of 3 dosage levels ( OROS MPH 18 , 36 , and 54 mg QD , and an assumed equivalent regimen of IR MPH 5 , 10 , and 15 mg given TID ) based on their pre study established clinical dose of IR MPH . PD measurements included Combined-Attention and Deportment scores on a rating scale of school behavior ( the Swanson , Kotkin , Agler , M-Flynn , and Pelham ) , global assessment s of efficacy , and activity monitor levels during academic seatwork . Serial blood sample s for PK analysis were taken predose , and then every 60 to 90 minutes until 11.5 hours postdose . Vital signs were assessed predose , and then every 1.5 to 2.5 hours until 11.5 hours postdose . RESULTS Of the 32 patients enrolled , 31 completed the study . The PK profiles for MPH after OROS MPH administration were similar under all conditions ( with normal , high-fat breakfast , or fasting ) . No bioequivalence tests of OROS MPH and IR MPH under various breakfast conditions were done because there were so few patients in each dose level of treatment . The two IR MPH conditions ( after normal breakfast and fasting ) were not compared . The drug-to-metabolite ratios ( area under the curve ) for all OROS MPH and IR MPH treatments were similar . OROS MPH and IR MPH provided a similar therapeutic effect , irrespective of breakfast conditions , as demonstrated by the Swanson , Kotkin , Agler , M-Flynn , and Pelham Attention and Deportment measures and global assessment s. No serious adverse events , no deaths , and no clinical ly significant changes in vital signs were reported , except for one patient who was discontinued early because of repeated systolic blood pressure elevations on study day 1 . CONCLUSIONS The results of this study demonstrate that in children with attention-deficit/hyperactivity disorder , administering OROS MPH with or without food produces similar PK and PD profiles
None of the mediators or moderators tested affected methylpheni date efficacy .
Academic improvements were small compared to symptom improvements ; qualitative changes limited to math .
Academic improvement is amongst the most common treatment targets when prescribing stimulants to children with ADHD .
Previous review s on stimulant-related academic improvements are inconclusive and focus on task engagement .
Recent literature suggests outcome -domain-specific medication effects that are larger for productivity than for accuracy .
The aims of this study are quantifying methylpheni date effects on academic productivity and accuracy for math , reading , spelling ; exploring the mediating or moderating effects of symptom improvements , demographic- , design - and disorder-related variables .