Chou 2012a.
Methods | A 10‐week non‐comparative observational study in 6 outpatient clinics identifying the optimal dose of OROS‐methylphenidate | |
Participants | Number of participants screened: not stated Number of participants included: 521 Number of participants followed up: 439 Number of withdrawals: 82 Diagnosis of ADHD: DSM‐IV (subtype: combined (65.6%), hyperactive‐impulsive (3.1%), inattentive (31.3%)) Age: mean 10.4 years (range 7‐17) IQ: normal Sex: 461 males, 60 females Methylphenidate‐naïve: none Ethnicity: Asian Country: Taiwan Comorbidity: ODD (4.4%), anxiety disorder (0.2%), other disorders (3.5%) Comedication: clonidine (0.6%), antipsychotics (0.4%) Sociodemographics: not stated Inclusion criteria:
Exclusion criteria:
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Interventions | Methylphenidate type: osmotic release oral system Methylphenidate dosage: participants receiving an immediate release methylphenidate dosage < 15 mg, 15‐30 mg, and > 30 mg day were converted to 18, 36, and 54 mg once daily Administration schedule: morning Duration of intervention: 10 weeks Treatment compliance: not stated |
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Outcomes | Parents or caregivers completed the Chinese version of the Barkley Side Effect Scale at each visit. An adverse event was any undesirable sign, symptom, or medical condition occurring after starting the therapy and was reported by investigators. Pre‐existing medical conditions/diseases were also considered adverse events if they worsened during treatment | |
Notes | Sample calculation: no Any withdrawals due to adverse events: not stated Ethics approval: approved by the Joint Institute Review Board, Taipei, Taiwan Funding: the study was supported by Janssen‐Cilag, Taipei, Taiwan Vested interests/authors' affiliations: Janssen‐Cilag. 5 authors had conducted clinical trials on behalf of Eli & Lilly Co and 1 on behalf of Janssen‐Cilag. 9 were speakers and consultants for Janssen‐Cila Key conclusions of the study authors: the findings suggest remission as a treatment goal for ADHD therapy by providing an optimal dosage of medication for children and adolescents with ADHD through using an effective and tolerable forced‐titration scheme Comments from the review authors: data are not pertinent to our review. Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes Supplemental information received through personal email correspondence with the authors in February 2014 (Chou 2014 [pers comm]) |