Zheng 2011.
Methods | A 6‐week multicentre, prospective, naturalistic, open‐label, pilot study evaluating the effectiveness and safety of osmotic release oral system (OROS) methylphenidate | |
Participants | Number of participants screened: not stated Number of participants included: 1447 Number of participants followed up: 1154 Number of withdrawals: 293 Diagnosis of ADHD: DSM‐IV (subtype: combined (56.8%), hyperactive‐impulsive (9.8%), inattentive (28.5%), unidentified type (3.4%)) Age: 9.53 (SD 2.35) years old (range 6‐16) IQ: not stated Sex: 1219 males, 228 females Methylphenidate‐naïve: not stated (no current methylphenidate treatment: 1304 (90%)) Ethnicity: Asian (97.8%), others (2.2%) Country: China Comorbidity: no Comedication: not stated Sociodemographics: not stated Inclusion criteria:
Exclusion criteria:
During the 6‐week treatment period, participants would be excluded if the following conditions occurred:
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Interventions | Methylphenidate type: osmotic release oral system (OROS) Methylphenidate dosage: 18, 36 or 54 mg once daily at the discretion of investigators. However, the recommended dosing strategy is: methylphenidate‐naïve: 18 mg; currently receiving 5 mg immediate release methylphenidate 2‐3 times a day: 18 mg OROS methylphenidate; currently receiving 10 mg immediate release methylphenidate 2‐3 times a day or a total daily dose of 40 mg immediate release methylphenidate: 36 mg OROS methylphenidate; and currently receiving 15 mg immediate release methylphenidate 2‐3 times a day or a total daily dose of > 45‐60 mg: 54 mg OROS methylphenidate Doses of OROS methylphenidate could be adjusted between a total daily dose range of 18 and 54 mg after 14 days of treatment by the investigator on the basis of safety and efficacy. At the end of the study 96.8% participants received an OROS methylphenidate dose of 18 mg, 3.1% 36 mg and 0.1% 54 mg Duration of intervention: 6 weeks Treatment compliance: 93.4% of the patients showed good compliance (defined as more than 80% adherence to the prescribed regimen) |
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Outcomes |
Non‐serious adverse events Blood pressure, pulse rate measurement, adverse event review were conducted by the investigator at baseline, week 2, 4 and 6 Parents rated the participant's sleep quality and were asked about the presence of motor and/or verbal tics at baseline, week 2, 4 and 6 |
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Notes | Sample calculation: not stated Ethics approval: not stated Funding: funded by Xi'an Jassen Pharmaceutical Ltd, China Key conclusions of the study authors: this open‐label, naturalistic study provides further evidence of effectiveness and safety of OROS methylphenidate in school‐aged children under routine practice Comments from the study authors: since the patients in this study only received 6‐weeks OROS methylphenidate treatment, the long‐term adverse events such as influence on growth and weight can not be observed. This is a limitation of this study because ADHD patients need long‐term treatment Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes Supplemental information requested through email correspondence with the first author in September 2013. No reply |