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

Garg 2014.

Methods An open‐label randomised parallel group clinical trial of methylphenidate and atomoxetine use for 8 weeks
Participants Methylphenidate group
Number of participants screened: not stated
Number of participants included: 33
Number of participants followed up: 26
Number of withdrawals: 7
Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (66.7%), hyperactive‐impulsive (6.1%), inattentive (27.3%))
Age: mean: 8.47 (SD 2.22), range: 6‐14 years old
IQ: > 70
Sex: 27 males (81.1%), 6 females (18.2%)
Methylphenidate‐naïve: 100%
Ethnicity: not stated
Country: India
Comorbidity: oppositional defiant disorder (15/45.5%), conduct disorder (1/3%)
Comedication: none
Sociodemographics: not stated
Inclusion criteria
  1. 6‐14 years old

  2. Diagnosed with ADHD according to DSM‐IV‐TR

  3. Having moderate to severe illness as assessed by Clinical Global Impressions Severity Scale (CGI‐S)


Exclusion criteria
  1. Patients with history of non‐response or adverse reactions to methylphenidate in the past

  2. Those who had taken any medication for ADHD in the past month

  3. Those with history of heart disease, seizures, pervasive developmental disorder, substance abuse, mental retardation or tic disorder were excluded

Interventions Methylphenidate type: immediate release
Mean methylphenidate dosage: 11.59 (2.83) mg/day, at conclusion of the study: 17.35 (7.52) mg/day (or 0.62 mg/kg/day)
Administration schedule: once or twice daily
Duration of intervention: 8 weeks
Treatment compliance: not stated
Outcomes The various side effects were noted on each assessment on the Adverse Events Checklist prepared for the study. It was a semi‐structured check list enlisting all the common side effects of methylphenidate and atomoxetine. The parents were asked to rate the severity of each side effects produced in their children as mild, moderate and severe. Those who reported mild side effects were continued on the same dose. For those who developed moderate severity of side effects, dose was reduced. Those who rated any adverse effect to be severe were taken out of the study after stopping the medication
Non‐serious adverse events:
18 (55%) patients developed side effects during the course of the study
The commonest reported adverse effect was reduced appetite
Notes Sample calculation: not stated
Ethics approval: clearance was obtained from the ethics committee of the Government Medical College and Hospital, Chandigarh
Funding/vested interest: none
 Key conclusions of the study authors: methylphenidate and atomoxetine are efficacious in Indian children with ADHD at lesser doses than previously used. Their efficacy and tolerability are comparable
 Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes, exclusion of non‐responders
 Supplemental information received through personal email correspondence with author in July 2016 (Arneja 2016 [pers comm])