Davari‐Ashtiani 2010.
| Methods | A 6‐week randomised, parallel, double‐blind clinical trial with 2 arms:
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| Participants | Number of participants screened: not stated Number of participants included: 34 Number of participants randomised to methylphenidate: 16 Number of participants followed up: 16 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (100%)) Age: mean 8.62, range 6‐12 years old IQ: normal Sex: not stated Methylphenidate‐naïve: 100% 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: not stated Methylphenidate dosage: initiated at 0.5 mg/kg/day and adjusted to the optimal effect. Maximum dose: 60 mg/day. Range: 0.3‐1 mg/kg/day Administration schedule: not stated Duration of intervention: 6 weeks Duration of titration period: not stated Treatment compliance: not stated |
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| Outcomes |
Serious adverse events: No serious adverse drug effects were observed during the trial Non‐serious adverse events Possible side effects were systematically recorded throughout the study and assessed using a checklist administered by a child psychiatrist on weeks 2, 4, 6 Decreased appetite (n = 11), decreased sleep (n = 7) |
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| Notes | Sample calculation: statistical power calculated on the basis of the projected group size, a response rate of 30% and an alpha level of 0.05. Ethics approval: yes, approved by the Ethics Committee of Shahid Beheshti University of Medical Sciences (Tehran, Iran). Funding/vested interests: this work was supported in part by the grant from the Behavioral Sciences Research Center of Shahid Beheshti University of Medical Sciences (Tehran, Iran) Key conclusions of the study authors: no significant differences were observed between the 2 protocols on the total scores of parent and teacher ADHD Rating Scale, but methylphenidate was superior to buspirone in decreasing the symptoms of inattention. The side effects of buspirone were mild and rare in comparison with methylphenidate Comments from the study authors:main limitations: small sample size, minimal dosage necessary for response and duration of treatment. The effect of buspirone on different DSM‐IV subtypes of the disorder was not explored Comments from the review authors: the article in Farsi presents the preliminary results, and the article in English presents the final results. Therefore, the data reported in the Farsi article are not used in our review Supplemental information received through personal email correspondence with the study authors in January 2014 (Davari‐Ashtiani 2014 [pers comm]) |
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