Remington 2001.
| Methods | Randomised control trial | |
| Participants | DSM‐IV diagnosis of Autistic disorder confirmed by two investigators, aged 10‐36 years | |
| Interventions | Three arms to trial ‐ used First Phase data comparing clomipramine with placebo | |
| Outcomes | Childhood Autism Rating Scales (CARS) Aberrant Behaviour Checklist (ABC) Dosage Treatment Emergent Symptom Scales (DOTES) Extrapyramidal Symptom Ratig Scale (ESRS) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "subjects were randomly assigned to one of three treatment groups using Latin Square design" |
| Allocation concealment (selection bias) | Low risk | "medications and placebo were packaged in similar capsules to maintain double‐blind component" |
| Blinding (performance bias and detection bias) Participants | Low risk | "medications and placebo were packaged in similar capsules to maintain double‐blind component" |
| Blinding (performance bias and detection bias) Personnel | Low risk | "medications and placebo were packaged in similar capsules to maintain double‐blind component" |
| Blinding (performance bias and detection bias) Outcome assessors | Unclear risk | no information provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | There was a big loss from all arms of the trial, and although 36 patients were randomised only 32 are reported on. |
| Selective reporting (reporting bias) | Low risk | Reported all that researchers had stated would report. |
| Other bias | Unclear risk | Risk of bias from cross‐over trial design is low, with appropriate data analysis (repeated measures univariate analysis of variance), and the order of receiving medication was randomised. There was felt to be a small risk of carry‐over effect biasing results as there was a short cross‐over period between treatment arms (one week). |