Claus 1991.
| Methods | Allocation: randomised (no further description). Blindness: double (described). Duration: 12 weeks (preceeded by one week placebo washout). Consent: written. Setting: multicentre. | |
| Participants | Diagnosis: schizophrenia (DSM‐III‐R). N=44. Sex: 28M, 14F. Age: 20‐66 years, mean ˜ 38 years. History: chronic, hospitalised. Exclusions: other significant physical or psychological illness, pregnant or nursing females. | |
| Interventions | 1. Risperidone: 2‐20mg/day, an initial dose of 2mg/day was adjusted as required days 1‐42, FD thereafter. N=21.
2. Haloperidol: 2‐20mg/day, an initial dose of 2mg/day was adjusted as required days 1‐42, FD thereafter. N=21. Diazepam, dexetimide, tybezatropine IM as required. |
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| Outcomes | Clinical improvement: 20% reduction of total PANSS.
Global effect: CGI improved/not improved
Adverse effects: various observed effects.
Leaving the study early. Unable to use ‐ Global effect: CGI (no SD). Mental state: PANSS, SADS‐C (no SD). Behaviour: NOISE‐30, Individual target symptom (visual analogue scale), sleep quality (visual analogue scale) (no SD). Physiological monitoring: ECG, lab tests (no data) Side effects: ESRS (no SD). |
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| Notes | Intention to treat analysis for adverse effects, two patients excluded from efficacy analysis. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |