Peuskens 1995.
Methods | Allocation: randomised (random permuted block procedure with randomisation list transferred to sealed envelopes). Blindness: double (no further description). Duration: 8 weeks (preceded by one week washout). Consent: not stated. Setting: multi‐centre, multi‐national. | |
Participants | Diagnosis: schizophrenia (DSM‐III‐R). N=1362. Age: mean ˜ 38 years. Sex: 894M, 467F. History: chronic, mean duration of illness ˜17 years, Exclusions: PANSS score < 60 | |
Interventions | 1. Risperidone: 1mg/day. N=229.
2. Risperidone: 4mg/day. N=227.
3. Risperidone: 8mg/day. N=230.
4. Risperidone: 12mg/day. N=226.
5. Risperidone: 16mg/day. N=224.
6. Haloperidol: 10mg/day. N=226. Medication titrated to fixed maintainance dose during week |
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Outcomes | Clinical improvement: 20% reduction PANSS.
Mental state:BPRS ‐ PANSS derived, PANSS.
Adverse effects: CGI, ESRS, modified UKU, use of antiparkinsonian medication.
Leaving the study early. Unable to use ‐ Physiological monitoring: ECG, lab tests (no data). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |