Jacobsson 1974.
| Methods | Allocation: randomised by pre‐established randomised code Blindness: double‐blind ‐ tablets of the same appearance and taste Duration: 4 weeks Design: parallel Setting: hospital Country: Sweden |
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| Participants | Diagnoisis: "acute psychotic syndromes of a schizophrenic type" N = 49 Age: 18‐60 years Sex: 23 M, 26 F History: suffering from acute psychotic syndromes of a schizophrenic type, either during their first episode or on a re‐occurrence of an acute stage Excluded: gross neurological or somatic disorders unrelated to the principal condition, alcoholism or drug addiction, and spontaneous remission |
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| Interventions | 1. Clotiapine: range: 40‐220 mg/d, maximum dose: 240 mg/d, mean dose: 125.2 mg/d. N = 23 2. Chlorpromazine: range: 200‐600 mg/d, maximum dose: 600 mg/d, mean dose: 404.5 mg/d. N = 26 |
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| Outcomes | Mental state: general, specific symptoms (Martens' Symptom Scale (S‐Scale)) Adverse effects: incidence of Parkinsonism Leaving the study early Unable to use ‐ Mental state: general ‐ average endpoint score (scale not named ‐ unsure if peer reviewed) Behaviour: Wing rating scale (no SD reported) Adverse effects: haematology, hepatic, ophthalmic (no SD reported), constipation, tiredness ‐ average change score (scale not named ‐ unsure if peer reviewed) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised: quote: "according to a pre‐established randomized code." |
| Allocation concealment (selection bias) | Unclear risk | No details provided for allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "clotiapine or 100 mg chlorpromazine were administered using the double‐blind technique" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "A separate envelope for each code‐number was also prepared in case it should be necessary to know what drug an individual patient was receiving" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data were addressed in the study. |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in the study. |
| Other bias | Unclear risk | Drugs were supplied by AstraZeneca, Mölndal. Source of funding not reported |