Gorman 2006.
Study characteristics | ||
Methods | Participants with ADHD took part in a randomly ordered, double‐blind, cross‐over clinical drug trial comprising 21 consecutive days of:
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Participants | Number of participants screened: not stated Number of participants included: 43 Number of participants followed up: 41 (21 boys, 20 girls) Number of withdrawals: 2 Diagnosis of ADHD: DSM‐IV (combined (n = 22), hyperactive‐impulsive (n = 0), inattentive (n = 19)) Age: mean 9.08 years (range 6.26‐12.55) IQ: mean 107.66 MPH‐naive: 37 (out of 41, 90%) Ethnicity: white (92.67%) Country: USA Setting: outpatient clinic Comorbidity: > 2 anxiety disorders (12.16%), lifetime affective disorder (2.46%), ODD or CD (49.28%) Comedication: 0% Other sociodemographics: mean 50.43 (range 22‐66) (Hollingsworth socioeconomic status) Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 dose of MPH and placebo Mean MPH dosage: final daily dose 33.12 mg ± 1.36 (SE), range 25‐50 mg/d (0.94 ± 0.02 mg/kg) Administration schedule: twice/d Duration of each medication condition: 21 days Washout before trial initiation: not stated Medication‐free period between interventions: from lunch to the following morning Titration period: 0.25 mg/kg twice/d (breakfast and lunch) on days 1‐2; 0.25 mg/kg twice/d, plus 0.125 mg/kg at 4:00 pm on days 3‐7; 0.3 mg/kg twice/d and 0.15 mg/kg at 4:00 pm on days 8 to 14; and 0.4 mg/kg twice/d, and 0.2 mg/kg at 4:00 pm on days 15‐21. All dosages were administered to the nearest 2.5 mg Titration: took place after randomisation Treatment compliance: not stated. 4 participants with ADHD had undergone previous trials of stimulant therapy ranging from 2 weeks to 7 months |
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Outcomes |
ADHD symptoms
Serious AEs
Non‐serious AEs
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Notes | Sample calculation: not described Ethics approval: yes Comment from trial authors
Key conclusions of trial authors
Comment from review authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: not stated Funding source: NIMH Email correspondence with trial authors: January 2014. We obtained supplemental information from trial authors. Trial authors do not have the files anymore; therefore we are not able to obtain all of the data requested |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Answer from trial author: "Table of random numbers were used to make the allocation process, such that numbers ending in an even digit corresponded to one order and those ending in an odd digit to another" (Krogh 2014c [pers comm] |
Allocation concealment (selection bias) | Low risk | Answer from trial author: "Table of random numbers were used to make the allocation process, such that numbers ending in an even digit corresponded to one order and those ending in an odd digit to another" (Krogh 2014c [pers comm] |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo capsules, identical in appearance and taste to those containing MPH, and administered on the same schedule |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Second author blinded. Placebo capsules, identical in appearance and taste to those containing MPH, and administered on the same schedule |
Incomplete outcome data (attrition bias) All outcomes | Low risk | When parents reported serious side effects (n = 5), their children’s dosages were reduced, or planned increments were omitted. However, trial authors noted "eliminating participants who could not tolerate their assigned dosage might potentially skew the sample" Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | High risk | Answer from trial author: "Event related potentials and performance measures on a cognitive task were not reported (I didn't attempt to publish the ERP data because the analyses I conducted did not yield significant results) ‐ And since we do not look at this outcome, we see it as low" (Krogh 2014c [pers comm]) |