Lyon 2010.
Methods | A cross‐over trial with 2 interventions:
10 children with ADHD and TD were given dexmethylphenidate on 1 visit and no medication on another (day 2 and 3), using a random cross‐over design |
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Participants | Number of participants screened: 51 Number of participants included: 13 Number of participants followed up: 10 Number of withdrawals: 3 Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (50%), inattentive (50%)) Age: mean 12.7 years old, range 8‐16 years old IQ: mean 104, range 85‐118 Sex: 9 males, 1 female Methylphenidate‐naïve: not stated Ethnicity: white 70%, African American 0%, Asian 0%, Hispanic 30%, others 0% Country: USA Comorbidity: Tourette's 100% Comedication: 70% Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 2 possible drug condition orders of (0.15 mg/kg) methylphenidate and placebo Mean methylphenidate dosage: 7.5 mg/day Administration schedule: once a day Duration of each medication condition: 1 day Washout prior to study initiation: not stated Medication‐free period between intervention: not stated Titration period: none Treatment compliance: not stated |
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Outcomes |
Non‐serious adverse events The Safety Monitoring Uniform Report Form (SMURF) (Greenhill et al. 2004) was administered by one of the investigators on day 1, and after TSP procedures on days 2 and 3 Adverse events were generally mild. 7 (70%) participants experienced ≥ 1 minor adverse event during the study. The most common adverse events possibly related to study drug were drowsiness or sedation (20%) and stomach discomfort (20%) |
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Notes | Sample calculation: not stated Ethics approval: all study procedures were approved by the institutional review boards (IRB) at the University of Wisconsin‐Milwaukee and New York University Langone Medical Center Key conclusions from study authors: preliminary results suggest that dexmethylphenidate does not appear to enhance tic suppressibility in children with ADHD and TD. First, there was a clear tic‐reduction effect, and not exacerbation, with a 1‐time dose of dexmethylphenidate compared to no medication in these children. Second, youths with TD and ADHD appear to be able to suppress their tics with a behavioural reward comparable to youths with TD without ADHD Comments from the study authors: some limitations of the study design need to be taken into account. First, our sample size was small and participants were recruited from a specialised clinic. Thus, findings may not generalise to non‐specialty settings. Second, 70% of participants were receiving medication for TD, anxiety, OCD, or asthma, and our results might have differed if the participants were not receiving concomitant medication. Third, investigators, parents, and participants were not blind to medication status, because medication was administered openly Comments from the review authors: ADHD outcome data are only available for 7 participants ('data from 3 participants were unusable as a result of computer malfunction') Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no |