Mesotten 1991.
| Methods | Allocation: randomised (no further description). Blindness: double (identical medication). Duration: 8 weeks (preceeded by one week washout). Consent: not stated. Setting: multicentre. | |
| Participants | Diagnosis: schizophrenia, other serious psychotic disorders (DSM‐III). N=60. Age: 20‐65 years, mean ˜ 40 years. Sex: 37M, 23F. History: hospitalised, mean duration of hospitalisation ˜ 5 years. Exclusions: continuous neuroleptic treatment for > 5 years, other significant physical of psychological illness, depot neuroleptics within 4 weeks of trial, pregnant or nursing females or those of reproductive age without adequate contraception. | |
| Interventions | 1. Risperidone: 2‐20 mg/day, and initial dose of 2mg/day was adjusted as required days 1‐28, FD thereafter. N=28. 2. Haloperidol: 2‐20 mg/day, an initial dose of 2 mg/day was adjusted as required days 1‐28, FD thereafter. N=32. | |
| Outcomes | Global effect: CGI improved/not improved.
Adverse effects: use of EPS medication, other various observed effects.
Leaving the study early.
Acceptability of treatment. Unable to use ‐ Global effect: CGI score (no SD). Mental state: BPRS (no SD). Behaviour: NOISE (no SD). Physiological monitoring: ECG, lab tests (insufficient data). Adverse effects: ESRS (no SD). |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |