Findling 2000.
Methods | Randomised double‐blind control trial of risperidone and placebo | |
Participants |
Setting: outpatients, 1 centre, inner city academic outpatient medical centre Sample size: 20; 10 active treatment, 10 placebo Sex: 19 male, 1 female Age range: 5 to 15 years Mean age: 9.2 (2.9) years (range 6 to 14 years) IQ range: IQ more than 70 Diagnosis: DSM‐IV of conduct disorder Inclusion criteria: Clinical Global Impression ‒ Severity score moderate severity; Child Behaviour Checklist aggression subscale T‐score 2 SD or more above mean for age and gender‐matched peers Comorbidity: moderate to severe ADHD excluded Withdrawn/dropouts: 11 withdrew (4 active treatment, 7 placebo) Other Interventions: psychosocial interventions not mentioned |
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Interventions |
Intended dose: for under 50 kg, 0.25 mg increasing to 1.5 mg; and for over 50 kg, 0.5 mg increasing to 3 mg Mean dose at endpoint: 0.028 (± 0.004) mg/kg per day (range 0.75 to 1.50 mg/day) |
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Outcomes |
Primary outcomes: Rating of Aggression Against People and Property Scale Secondary outcomes: Conners' Parent Rating Scale ‒ conduct problem subscale, Child Behaviour Checklist, Clinical Global Impression ‐ Severity, Clinical Global Impression ‐ Improvement Follow‐up interval: 10 weeks |
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Notes |
Imputation method for incomplete data: unclear from the published study Funding/support
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A random number list. The list was kept in the Center for Drug Research and not was not accessible to either PI or other study raters. |
Allocation concealment (selection bias) | Low risk | A random number list. The list was kept in the Center for Drug Research and not was not accessible to either PI or other study raters. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Risperidone and placebo matched in appearance. The blind was not broken during the course of the trial. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of the 10 youths assigned to risperidone, 6 completed the entire study (40% attrition): "3 youths who were assigned to receive risperidone were withdrawn by their guardian because of lack of effect, and 1 youth who received risperidone was withdrawn from the study during week 4 because of the development of a rash" (p 511). Only 3 youths who received placebo finished the trial (70% attrition): "4 patients assigned to placebo were withdrawn from the protocol by their guardians because of lack of benefit, 2 more were withdrawn from the study by the PI because of non‐compliance with study procedures, and 1 youth randomly assigned to placebo was lost to follow‐up" (p 511). |
Selective reporting (reporting bias) | Unclear risk | Protocol unavailable. |
Other bias | High risk | Small sample size and therefore limited power to detect differences. |