Kratochvil 2002.

Methods	A randomised, open‐label, parallel, cohort study of Atomoxetine Methylphenidate
Participants	Number of participants screened: 319 Number of participants included: 228 Number randomised to methylphenidate: 44 Number followed up: 25 Number of withdrawals: 19 Diagnosis of ADHD: DSM‐IV (subtype: combined (77.3%), inattentive (22.7%)) Age: mean 10.4 (SD 2.1) years old IQ: > 70 Sex: 44 males Methylphenidate‐naïve: not stated Ethnicity: white: 81.8%, others: 18.2% Country: USA and Canada Comorbidity: ODD 59.1%, major depressive disorder 13.6%, elimination disorder 11.4% Comedication: not stated, but other psychoactive medication not permitted Sociodemographics: not stated Inclusion criteria DSM‐IV diagnosis of ADHD Severity score of ≥ 1.5 SD above age and gender norms on the ADHD‐IV Rating Scale‐Parent Version: investigator Administered (ADHD RS) Age 7‐15 Exclusion criteria History of bipolar or psychotic disorders Motor tics Family history of Tourette syndrome Substance abuse Methylphenidate non‐responders (from a previous trial of methylphenidate of ≥ 2 weeks of treatment with at least 1.2 mg/kg per day) Serious medical illness
Interventions	Methylphenidate type: not stated Methylphenidate dosage: initial dose 5 mg 1‐3 times daily with an ascending dose titration based on the investigator's assessment of clinical response and tolerability Mean methylphenidate dosage: 0.85 SD 0.53 mg/kg pr day, or 31.3 SD 18.7 mg/day Median dose: 0.74 mg/kg/day or 27.5 mg/day. Total daily dose was not to exceed 60 mg Administration schedule: 1‐3 times daily, based on clinical response and tolerability Duration of intervention: 10 weeks Treatment compliance: not stated Washout period prior to treatment ‐ duration not specified
Outcomes	Non‐serious adverse events At weekly visits: ECG, liver function, blood count, urinalysis, open‐ended questions
Notes	Sample calculation: yes, but sample size and power computations were performed to answer questions specific to the relapse‐prevention portion of the study which followed the open‐label period described in this paper Ethics approval: yes Funding/vested interest: study funded by Eli Lilly and Co Authors' affiliations: the authors are either employees or paid consultants and/or investigators of Eli Lilly. The employees are also shareholders Key conclusions of the study authors: the results of this study provide preliminary evidence that the magnitude and profile of symptom reduction associated with atomoxetine administration and its tolerability are comparable to that observed with methylphenidate Comments from the study authors: in our trial, investigators had latitude in the frequency and timing of methylphenidate dosing, and methylphenidate outcomes might have been different had all methylphenidate‐treated patients been required to receive fixed dosing on a thrice‐daily basis. A relatively large proportion of patients in both groups withdrew from the study early. No single reason appears to have accounted for this, but this could limit the interpretability of the results. The groups were not well matched for gender. Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes Supplemental information regarding IQ received through personal email correspondence with the authors in June 2014 (Kratochvil 2014 [pers comm])