King 2009.
Study characteristics | ||
Methods | Parallel trial of citalopram versus placebo | |
Participants | Inclusion criteria:
Exclusion criteria: details not provided Location/setting: s6 academic medical centres in the USA Sample size: 149 (73 children were randomised to citalopram and 76 to placebo) Number of withdrawals/dropouts: placebo: 13 withdrew (7 AEs, 1 protocol violation, 5 withdrew consent) Citalopram hydrobromide: 13 withdrew (1 serious AE, 8 AEs, 2 protocol violations, 2 withdrew consent) Mean age: 9.4 years Gender: 128/149 boys IQ: 43% had nonverbal IQ > 70 Baseline ABC‐I or other BoC: citalopram ABC‐I 13.2; placebo 11.2; self‐injurious behaviour 2.8 (citalopram); 2.6 (placebo) Concomitant medications: psychotropic medication not allowed during the study. Only sleep medications allowed History of previous medications: details not provided |
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Interventions | Intervention (citalopram hydrobromide) for 12 weeks: 10 mg/5 mL. Mean maximum dose was 16.5 mg/day (± 6.5 mg) Comparator (placebo) for 12 weeks: equivalent placebo |
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Outcomes | Primary outcomes:
Secondary outcomes: none reported Timing of outcome assessments: AEs assessed at bi‐weekly visits; ABC‐I and self‐injury measured at baseline and endpoint |
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Notes | Study start date: April 2004 Study end date: October 2006 Source of funding: all authors received salary contributions from the National Institutes of Health, which supported this study. Conflicts of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomly assigned to citalopram or placebo using permuted blocks with randomly varying block sizes stratified by site and by age (5‐11 vs 12‐17 years) |
Allocation concealment (selection bias) | Unclear risk | Details not provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Two masked clinicians met with participants during each scheduled evaluation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The evaluating clinician monitored efficacy and was blinded to AEs |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | LTFU citalopram: 13 withdrew, 1 due to serious AE; 8 AEs; 2 protocol violations; 2 consent withdrawn LTFU placebo: 13 withdrawn, 7 AEs; 1 protocol violation; 5 consent withdrawn |
Selective reporting (reporting bias) | Low risk | The trial protocol was recorded on Clinicaltrials.gov and outcomes were reported in the paper. |
Other bias | High risk | Study authors all work with/for pharmaceutical companies |