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
Exclusion criteria
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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 |
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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 |
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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]) |