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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

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:
  1. Age 6‐19 years

  2. ADHD according to DSM‐IV

  3. Treatment with immediate‐release methylphenidate (< 70 mg/day) for ≥ 1 month, without severe adverse events or possible contraindications

  4. Participant/parent written informed consent

  5. Participants must be living with the parent/caregiver who can complete the questionnaires during the study

  6. Participants or parent/caregivers without any psychotic disease or any mental situation which may cause the concern to properly complete the questionnaires


Exclusion criteria:
  1. Any systemic disease or clinically significant gastrointestinal problem

  2. Any comorbid psychiatric disorders, except for conduct disorder and oppositional disorder

  3. Known to be non‐responders to methylphenidate

  4. Known or suspected mental retardation or significant learning disorder

  5. Glaucoma or ongoing seizure disorder

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
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])