Goez 2012.
Methods | A randomised, double‐blind, cross‐over study design where participants were randomly assigned to receive a single dose of either
Follow‐up 90 minutes |
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Participants | Number of participants screened: not stated Number of participants included: 28 Number of participants followed up: 28 Number of withdrawals: none Diagnosis of ADHD: DSM‐IV (subtype; combined (100%)) Age: mean 10.1 years, range 6‐15 years old IQ: > 70 Sex: 26 males, 2 females Country: Canada and Israel Methylphenidate‐naïve: not stated Ethnicity: not stated Comorbidity: no major psychiatric conditions Comedication: not stated Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Methylphenidate type: not stated Methylphenidate dosage: 10 mg Administration schedule: single dose Duration of treatment: single dose Wash‐out: 2 weeks for those who received modafinil first Treatment compliance: not stated |
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Outcomes |
Non‐serious adverse events: Patients and their families were subsequently contacted and requested to report any adverse effects that might have occurred 7 participants (25%) reported adverse events, including abdominal pain, diarrhoea, hyposomnia, and headaches. All adverse events were minimal and resolved spontaneously All appear to have been rated up to 90 minutes following administration of methylphenidate |
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Notes | Sample calculation: not stated Ethics approval: yes Funding: the authors received no financial support for the research, authorship, and/or publication of this article Vested interests/authors' affiliations: the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Key conclusions of the study authors: Modifinil may serve as an effective alternative treatment for ADHD in paediatric patients who do not respond well to methylphenidate or other stimulants Comments from the study authors: adverse events for both agents were mild and self‐limited. The study do not provide any information on long‐term drug effects and long‐term adverse effects. Furthermore, small number of participants and even smaller number of participants for whom numerical scores could be obtained. Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: participants who have had an hypersensitivity reaction to either drug were excluded Supplemental information regarding the protocol and side effects requested from the study authors in October 2013 with no reply |