Gordon 1993.
Study characteristics | ||
Methods | Cross‐over trial of clomipramine, desipramine, and placebo | |
Participants | Inclusion criteria:
Exclusion criteria:
Location/setting: outpatient clinic, USA Sample size: 24 in total (cross‐over) Number of withdrawals/dropouts: 1 in clomipramine group and 1 other dropout although group was not specified. Gender: 15/24 male Age range: 6‐18 years IQ range: 30‐107 Baseline ABC‐I or other BoC: not reported Concomitant medications: not reported History of previous medications: not reported |
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Interventions | Intervention 1 (clomipramine) for 5 weeks: mean final dose was 152 mg/day (SD 56), 4.3 mg/kg/day (SD 0.8). The initial dosage was 25 mg/day, and titrated to a maximum of 5 mg/kg per day or 250 mg/day usually between weeks 2 and 3 Intervention 2 (desipramine) for 5 weeks: mean final dose was 127 mg/day (SD 52). 4.0 mg/kg/day (SD 1.2). The initial dosage was 25 mg/day, titrated to a maximum of 5 mg/kg per day or 250 mg/day usually between weeks 2 and 3 Comparator (placebo) for 5 weeks: equivalent placebo |
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Outcomes | Primary outcomes: AEs Secondary outcomes: none reported Timing of outcome assessment: week 5 (endpoint) |
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Notes | Study start date: not reported Study end date: not reported Source of funding: not reported Conflicts of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomisation was performed by the National Institutes of Health pharmacy using a random‐number table". |
Allocation concealment (selection bias) | Unclear risk | Details not provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Details of blinding were not provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Details not provided |
Incomplete outcome data (attrition bias) All outcomes | High risk | LTFU: clomipramine/desipramine 2; 1 in the clomipramine/ desipramine group because of violent outbursts and 1 because the group home administered his medicine to the wrong participant. |
Selective reporting (reporting bias) | Unclear risk | Outcomes that were mentioned in the paper were reported. No protocol was available. |
Other bias | Unclear risk | No baseline comparisons were reported by group. |