Kaneko 1969.
Methods | Allocation: implied randomisation Blindness: double‐blind ‐ tablets of the same external form Duration: 10 weeks (2 weeks placebo before the study started‐ 8 weeks for intervention) Design: parallel Setting: hospital Country: Japan |
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Participants | Diagnosis: schizophrenia N = 68 Age: 18‐60 years Sex: 52 M, 16 F History: including symptoms of severe excited state, stuporous state, hallucination, delusion or apathy. Symptoms were evaluated by a simplified scale for evaluation of psychogenic symptoms (for schizophrenia and for use by doctors) as 12 items, and the intensity of each item was assessed in five grades. Excluded: marked exacerbation or serious side effects, complete remission |
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Interventions | 1. Clotiapine: maximum dose: 240 mg/d. N = 34 2. Chlorpromazine: maximum dose: 600 mg/d. N = 34 |
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Outcomes | Mental state: average change score (PANSS positive and negative sub‐scale) Adverse effects: movement disorders, central nervous system, weight gain, thirst Leaving the study early Unable to use Mental state: improvement using Keio‐Gijuku University type, simplified scale, (no mean or SD) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | No information was provided for randomisation |
Allocation concealment (selection bias) | High risk | No information was provided for allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Employed as the experimental method in the present study. was the double‐blind, controlled technique " |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data and attrition were addressed in the study. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in the study. |
Other bias | Unclear risk | Source of funding not reported |