Mohammadi 2012b.
Methods | A a single‐centre randomised, double‐blind, parallel‐group clinical trial of methylphenidate use for 6 weeks | |
Participants | Number of patients screened: 53 Number included: 46 Number randomised to methylphenidate: 23, buspirone: 23 Number followed up in each arm: methylphenidate: 20 and buspirone: 20 Number of withdrawals in each arm: methylphenidate: 3 and buspirone: 3 Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (100%)) Age: mean: 9.70 (SD 3.18), range: 6‐14 years old IQ: above 70 Sex: 13 males, 7 females Methlphenidate‐naïve: 100% (n = 20) Ethnicity: not stated Country: Iran Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria:
Exclusion criteria:
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Interventions | Methylphenidate type: immediate release (Ritalin) Mean methylphenidate dosage: 20‐30 mg/day depending on weight (20 mg/day for < 30 kg and 30 mg/day for > 30 kg) Administration schedule: not stated Duration of intervention: 6 weeks Treatment compliance: not stated |
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Outcomes | Adverse effects were systematically recorded at each visit (baseline, 3 weeks, and 6 weeks) using a checklist (not otherwise specified) that comprised 20 side effects | |
Notes | Sample calculation: not stated Ethics approval: the study was approved by the Institutional Review Board (IRB) of Tehran University of Medical Sciences (grant No: 8643) Funding/vested interests: this study was supported by a grant from Tehran University of Medical Sciences (grant no: 8643) Any withdrawals due to adverse events: no Authors' affiliations: not stated Key conclusions of the study authors: the results of this study suggest that administration of buspirone has no comparable efficacy in comparison with methylphenidate in the treatment of ADHD. Nevertheless, in our study, those in the buspirone group experienced fewer adverse events than the methylphenidate group in particular regarding decreased appetite, headache and insomnia Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no Supplemental information requested from the authors twice through email correspondence in June 2016. No reply |