Skip to main content
. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

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
  1. Out clinic patient

  2. 6‐16 years

  3. Weight between 20 and 60 kg

  4. ADHD according to DSM‐IV, confirmed by structured diagnostic interview using Schedule for Affective Disorders and Schizophrenia for School‐Age Children ‐ Present and Lifetime Version with a score of ≥ 25 for boys or ≥ 22 for girls, or > 12 for a specific subtype on the ADHD Rating Scale‐ IV Parent Version: Investigator administrated and scored, as well as Clinical Global Impressions‐ADHD‐Severity ≥ 4


Exclusion criteria
  1. Any history of bipolar, psychotic or pervasive developmental disorders

  2. Suicidal risk

  3. Ongoing use of psychoactive medications other than the study drug

  4. Patients with motor tics

  5. A diagnosis or family history of Tourette syndrome

  6. Patients meeting DSM‐IV criteria for anxiety disorder

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
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:
  1. Anorexia: 1

  2. Decreased appetite: 2

  3. Nausea: 1

  4. Dizziness: 1

  5. Palpitations: 1

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