Borison 1991.
Methods | Allocation: randomised (no further description). Blindness: double (medication identical). Duration: 6 weeks (preceeded by one week placebo washout). Consent: not stated. Setting: hospital. | |
Participants | Diagnosis: schizophrenia (DSM‐III‐R). N=160. Sex: 154M, 6F. Age: 21‐63 years, mean ˜ 40 years. History: chronic, mean duration of illness ˜ 15 years. Exclusions: other significant physical or psychological illness, abnormal lab results, depot antipsychotics within 2 weeks of trial, other psychotropic medication within 3 days of trial, recent substance abuse, non response to classic neuroleptics, child bearing potential. | |
Interventions | 1. Risperidone: 1‐10mg/day, initial dose of 1mg/day adjusted as required days 1‐14, FD thereafter. N=53.
2. Haloperidol: 2‐20mg/day, initial dose of 2mg/day adjusted as required days 1‐14, FD thereafter. N=53.
3. Placebo: tablet number adjusted as required days 1‐14, FD thereafter. N=54. lorazepam,sodium amytal, chloral hydrate, benztropine or trihexyphenidyl as required. |
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Outcomes | Global effect: BPRS, CGI improved/not improved.
Side effects: various observed effects, use of antiparkinsonian medication.
Leaving the study early. Unable to use ‐ Global effect: CGI score (no SD). Mental state: BPRS, SANS (no SD). Physiological monitoring: ECG, lab tests (insufficient data) Side effects: ESRS, AIMS (no SD). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |