Chouinard 1992.
| Methods | Allocation: randomised.
Blindness: double blind.
Duration: 7‐day single‐blind placebo washout period plus 8‐week treatment period. Setting: inpatients, at six centres in Canada. Design: multicentre, parallel group. |
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| Participants | Diagnosis: chronic schizophrenia (DSM III‐R). N = 135. Age: 19‐67 years. Sex: male and female. Length of illness: mean ˜ 2.0 years, SD ˜ 3.4 years. Inclusion criteria: total PANSS score between 60 and 120. Exclusion criteria: pregnant or lactating women or women without adequate contraception, mental disorders other than schizophrenia, neurological disorders, psychoactive substance use or alcohol abuse. | |
| Interventions | 1. Risperidone: dose 2 mg/day, N = 24.* 2. Risperidone: dose 6 mg/day, N = 22. 3. Risperidone: dose 10 mg/day, N = 22. 4. Risperidone: dose 16 mg/day, N = 24. 5. Placebo, N = 22. 6. Haloperidol: dose 20 mg/day, N = 21. | |
| Outcomes | Mental state: PANSS, BPRS. Leaving the study early. Global state: CGI. Adverse effects: ESRS, UKU Side Effect Rating Scale, concomitant sedative/hypnotic use. Unable to use: Physiological measures: blood pressure, heart rate in supine and standing positions, ECG, biochemistry, hematology, urine analysis (no data reported). |
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| Notes | *Fixed dose. We included data only from the 6 mg/day arm, as this was the closest dose to what would be used in routine clinical practice. This arm had a differential leaving the study early rate with 45% in the risperidone arm leaving the study early compared to 68% in the placebo arm (overall participants leaving the study early was greater than 50%). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised, blocks of 12. |
| Allocation concealment (selection bias) | Unclear risk | Not stated. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double blind: "identical tablets" (p27). |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | LOCF, ITT analysis used. |
| Selective reporting (reporting bias) | Low risk | Outcomes listed in papers all reported. |
| Other bias | High risk | Supported by a grant from the Janssen Research Foundation. |