Wang 2007.
| Methods | A multicountry, multicentre, randomised, double‐blind, 8‐week study in children and adolescents with ADHD to test the hypothesis that atomoxetine is non‐inferior to methylphenidate on conventional ADHD symptom measures | |
| Participants | Number of participants screened: 361 Number of participants included: 166 included Number of participants followed up: 152 Number of withdrawals: 14 Diagnosis of ADHD: DSM‐IV (subtype: combined (57.2%), hyperactive‐impulsive (3.6%), inattentive (39.2%)) Age: 9.9 (SD 2.3) years IQ: not stated Sex: 134 males (80.7%), 32 females (19.3%) Methylphenidate‐naïve: 74.7% Ethnicity: Asian (91.6%), Hispanic (8.4%) Country: China (n = 242), Korea (n = 60), Mexico (n = 28) Comorbidity: ODD (17.5%) Comedication: not stated Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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| Interventions | Methylphenidate type: immediate release Methylphenidate dosage: 0.2‐0.6 mg/kg/day Administration schedule: morning and lunch Duration of intervention: 8 weeks Treatment compliance: the study completion rate was high 91.6% Titration: treatment titrated from 0.2mg/kg/day to 0.4 mg/kg/day on Day 5 and either maintained or titrated upward or downward within the range 0.2‐0.6 mg/kg/day |
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| Outcomes |
Non‐serious adverse events Tolerability measures ‐ assessment of treatment emergent adverse events via open‐ended questions Monitoring of vital signs ‐ ECG and clinical laboratory tests (chemistries, haematology and urinalysis) 6 patients (3.6%) discontinued due to:
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| Notes | Sample calculation: yes, approximately 330 patients between the 2 arms Ethics approval: not stated Funding: not stated Vested interest/authors' affiliations: not stated Key conclusions of the study authors: atomoxetine was non‐inferior to methylphenidate in improving ADHD symptoms based on response rates. Treatment‐emergent adverse effects experienced significantly more frequently in the atomoxetine group compared with the methylphenidate group Supplemental information requested through personal email correspondence with the authors in January 2014 with no reply |
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