Galland 2010.
| Methods | A cross‐over trial with 2 interventions:
Phases: 2 Part of a case‐control study: ADHD group randomly assigned to 2 nights on and 2 nights off of methylphenidate versus non‐medicated non‐ADHD control group |
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| Participants | Number of patients screened: not stated Number included: 30. Participants were randomly assigned to methylphenidate or no treatment Number followed up: 27 for cross‐over RCT, 28 for observational data Number of withdrawals: 3 for RCT, 2 for observational data RCT Diagnosis of ADHD: DSM‐IV (subtype: combined (78%/21), inattentive (22%/6)) Age: mean: 10 years 6 months, range: 6 years 7 months to 12 years 4 months IQ: above 70 Sex: 21 males, 6 females Methylphenidate‐naïve: 0% Ethnicity: white: 23, Maori: 1, other: 3 Country: New Zealand Comorbidity: oppositional defiant disorder: 9 (33%), specific phobia: 1 (4%) Comedication: no Sociodemographics: mean deprivation index: 5.5 Inclusion criteria
Exclusion criteria
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| Interventions | Participants were randomly assigned to methylphenidate or no medication. Methylphenidate type: Ritalin Mean methylphenidate dosage: not stated Administration schedule: 7 children had standard methylphenidate formulation once daily, 9 twice daily and 2‐3 times daily; 4 children had slow release alone, 4 in combination with once daily standard and 1 in combination with twice daily standard formulation Duration of intervention: 2 nights Washout prior to study initiation: none Medication‐free period between interventions: not clear, there was 5 to 7 days between medication and non‐medication phases Titration period: none, participants had been treated with methylphenidate for a median of 3 years 9 months (range 3 months to 6 years 8 months). ADHD children were randomised to either the first night as a medication‐ and caffeine‐free night for 48 hours prior to each study night, or a medication night where they maintained their methylphenidate dosage regimen 48 hours prior to each study night, but remained caffeine‐free Treatment compliance: urinary methylphenidate was reported as detected/or not detected. No control children returned a positive test on either night |
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| Outcomes |
Non‐serious adverse events: Standard polysomnographic (PSG) recordings on the second night of 48 hours on or off MPH Sleep questionnaire (28‐item), completed by the parent (predominantly mother) over that week General adverse events, parent rated, observational data |
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| Notes | Sample calculation: not reported Ethics approval: yes, Otago Ethics Committee approved the study Funding/vested interests/authors affiliations: the project was supported by a grant from the Health Research Council of New Zealand Key conclusions from study authors: findings suggest that methylphenidate reduces sleep quantity but does not alter sleep architecture in children diagnosed with ADHD Comments from the study authors: 1. It is possible that the longer sleep duration and shorter sleep latency on the off‐ compared to on‐medication night could be interpreted as purely rebound, or that the on‐medication night reflects a truer baseline and the off‐medication night reflects a medication withdrawal effect 2. The dosages and formulations of methylphenidate were not standardised 3. Only 1 PSG recording was conducted for each condition, which means the information collected could be subject to a first‐night effect Comments from the review authors: we considered this a RCT study even though the authors describe it as a case‐control study, because the ADHD children were randomly assigned to on‐ or off‐methylphenidate. Only observational data on adverse events is used here Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated Supplemental information received through personal email correspondence with the authors in August 2014 (Galland 2014 [pers comm]) |
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