Jaselskis 1992.
Study characteristics | ||
Methods | Cross‐over trial of clonidine versus placebo | |
Participants | Inclusion criteria:
Exclusion criteria:
Location/setting: outpatients clinic, USA Sample size: 8 in total (cross‐over) Number of withdrawals/dropouts:none reported Gender: 8 male Mean age: 8.1 years IQ: 59 Baseline ABC‐I or other BoC: none reported Concomitant medications: 0% History of previous medications: medications were not allowed in the month prior to the study. |
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Interventions | Intervention (clonidine) for 6 weeks: clonidine was provided at 0.025 mg strength. Clonidine was tapered up over 2 weeks to a dose of 4‐10 ug/kg/day (0.15‐0.20 mg/day) in 3 doses per day. Comparator (placebo) for 6 weeks: identical placebo tablets were provided in a 0.025 mg strength. Placebo was tapered up over 2 weeks to a dose of 4‐10 ug/kg per day (0.15‐0.20 mg/day) in 3 doses per day. |
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Outcomes | Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985) Secondary outcomes: none reported Timing of outcome assessment: ABC‐I rated weekly by teachers; AEs recorded weekly however not reported |
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Notes | Study start date: not reported Study end date: not reported Source of funding: "supported in part by the Harris Center for Developmental Studies (Chicago, IL) and National Institute of Mental Health Child and Adolescent Mental Health Academic Award K07 MH00822 (to E.C.)" … "Catapres and matched placebo tablets were provided as a gift from Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, CT)". Conflicts of interest: none declared Trial registry: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Details not provided except for, quote: "The subjects were randomly assigned by a non‐rating clinician whose only clinical contact with patients and parents occurred during the diagnostic phase and after the completion of the study for each patient." |
Allocation concealment (selection bias) | Unclear risk | "Tablets were placed in sealed envelopes designated for each day of the study" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "All raters (parents, teachers and clinicians) were blind to drug order until ratings were completed" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "all raters (parents, teachers, and clinicians) were blind to drug order until ratings were completed" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only 8 participants were analysed in the trial and individual data were not recorded. |
Selective reporting (reporting bias) | High risk | No baseline scores were recorded despite "three sessions that were done at baseline". "Clinician ratings were only made at the end of each treatment period" and "none of the clinician ratings showed significant differences between placebo and clonidine" and "weekly teacher ratings included the Abberant Behaviour Checklist". Side effects were monitored weekly however not reported. |
Other bias | High risk | Quote: "clonidine and identical placebo tablets were provided...by Boehringer Ingelheim Pharmaceuticals, Inc" |