Chouinard 1993a.
| Methods | Allocation: randomised (no further description). Blindness: double (identical tablets). Duration: 8 weeks (preceeded by one week washout). Consent: written. Setting: multicentre. | |
| Participants | Diagnosis:schizophrenia (DSM‐III‐R). N=135. Sex: 96M, 39F. Age: 19‐67 years, mean ˜ 37 years. History: chronic, hospitalised with mean duration of current hospitalisation ˜ 2 years. Exclusions: other significant physical or psychological illness, pregnant or nursing females, females without adequate contraception, substance abuse. | |
| Interventions | 1. Risperidone: 2mg/day FD. N=24.
2. Risperidone: 6mg/day FD. N=22.
3. Risperidone: 10 mg/day FD. N=22.
4. Risperidone: 16mg/day FD. N=24.
5. Haloperidol: 20mg/day FD. N=21.
6. Placebo. N=22. chloral hydrate, benzodiazepine, procyclidine or biperidin as required. |
|
| Outcomes | Clinical improvement: 20% reduction of total PANSS score.
Global effect: CGI score.
Mental state: BPRS, PANSS.
Adverse effects: ESRS, observed events on the UKU*, use of antiparkinsonian and/or sedative medication.
Leaving the study early. Unable to use ‐ Physiological monitoring: ECG, lab tests (no data) |
|
| Notes | Only haloperidol data used. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |