Marder 1994.
Methods | Allocation: randomised (in blocks of 12). Blindness: double (no further description). Duration: 8 weeks (preceeded by one week placebowashout). Consent: written. Setting: hospital | |
Participants | Diagnosis: schizophrenia (DSM‐III‐R). N=388. Age: 18‐65 years, mean ˜ 37 years.. Sex: 340M, 48F. History: duration of illness, mean 15.7 years; duration of current hospitalisation, mean 29 weeks; number of previous hospitalisations, mean 9.1, range 0‐61. Setting: hosptial. Exclusions: PANSS score < 60, people with schizoaffective disorder | |
Interventions | 1. Risperidone: 2mg/day. N=63.
2. Risperidone: 6mg/day. N=64.
3. Risperidone: 10mg/day. N=65.
4. Risperidone: 16mg/day. N=64.
5. Haloperidol: 20mg/day. N=66.
6. Placebo: N=66.
Medication titrated to fixed maintainance dose during week 1. Chloral hydrate, lorazepam, EPS medication as required. |
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Outcomes | Clinical improvement: 20% reduction in total PANSS.
Time to clinical improvement.*
Global effect: CGI improved/not improved, CGI score.
Mental state: BPRS, PANSS.
Adverse effects: ESRS, various observed effects.
Leaving the study early. Unable to use ‐ Physiological monitoring: ECG, lab tests (no data). Adverse effects: UKU (used modified version of this scale). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |