Su 2015.

Methods	A multicentre, prospective, single‐arm, open‐label study on methylphenidate use for 8 weeks with extended observation for up to 24 weeks
Participants	Number of participants screened: 248 Number of participants included: 239 Number of participants followed up: 205 Number of withdrawals: 34 Diagnosis of ADHD: DSM‐IV (subtype: combined 61.1%, predominantly inattentive type: 34.3%, predominantly hyperactive‐impulsive type: 3.8%, not specified: 0.8%) Age: mean: 9.2 (SD 2.02) years old (range 6‐16) IQ: not stated Sex: 203 male, 36 females Methylphenidate‐naïve: all the children were psychotropic drug naïve or had received anti‐ADHD drugs (including OROS‐methylphenidate, atomoxetine, monoamine oxidase inhibitors, clonidine, other α2‐adrenergic receptor agonists, tricyclic antidepressants, theophylline, and bishydroxycoumarin) for 6 months or longer before the trial with the treatment course not more than 1 month or were currently having effective immediate release methylphenidate treatment Ethnicity: Asian 94.6%, other 5.4% Country: China Comorbidity: not stated Comedication: recorded, but not stated Sociodemographics: not stated Inclusion criteria: DSM‐IV ADHD diagnosis 314.00 and 314.01 by evaluation with Kiddie Schedule for Affective Disorders and Schizophrenia 6‐16 years of age Body weight 20‐60 kg Exclusion criteria: History of bipolar I or II affective disorder, anxiety disorder, schizophrenia, mental retardation, pervasive development disorder, cardiovascular disease Diseases that may be aggravated because of accelerated pulse or high blood pressure including hypertension, glaucoma, tic disorder including Tourette syndrome Family history of tic disorder
Interventions	Methylphenidate type: osmotic release oral system (OROS) Methylphenidate dosage: 18 mg/day, 36 mg/day and 54 mg/day Administration schedule: for methylphenidate‐naïve dose participants: adjustment phase for 3 weeks, optimal dosage treatment for 5 weeks. For non‐naïve participants: 18 mg/day for previous 5 mg 2‐3 times a day, 36 mg/day for previous 10 mg 2‐3 times a day and 54 mg/day for previous 15 mg 2‐3 times a day or higher Duration of intervention: 8‐24 weeks Treatment compliance: most patients (> 90%) in the full analysis set had compliance between 80% and 120%, during the 8‐ and 24‐week treatment periods
Outcomes	Safety and tolerability were monitored throughout the study by the evaluation of the incidence and type of treatment emergent adverse events and changes in clinical laboratory test results, vital signs, sleep status, tics, appetite, height, and weight
Notes	Sample calculation: none Ethics approval: approved the institutional review board of Peking University sixth Hospital and other independent ethics committees at all sites Funding/vested interests: sponsored by Xi'an Janssen Pharmaceutical Ltd, and supported by the Major State Basic Research Development Program of China. YW has served on advisory boards of Xi'an Janssen Pharmaceutical Ltd and Eli Lilly & Company. JZ and JQ are full‐time employees of Xi'an Janssen Pharmaceutical Ltd. Key conclusions of the study authors: most of the children experienced symptom relief with no severe adverse events. The OROS‐methylphenidate at the dosage levels of 18 mg, 36 mg, and 54 mg once daily was generally well tolerated in Chinese children with ADHD between the ages of 6‐16 years Comments from the study authors: an open‐label, non‐comparator, non‐randomised study design is a major limitation for this study. No blinded trained clinician raters collected the study data. Also, the outcome measures were mainly based on the parent reports. As the role of measurement in ADHD makes school settings critical, hence, the data of ADHD symptom expression in school settings are not presented. To further improve this situation, we recommend the incorporation of direct evaluations from teachers/instructors in the follow‐up studies in China Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated Supplemental information requested through personal email correspondence with the authors in May 2016. No reply