Blin 1996.
Methods | Allocation: randomised (no further description). Blindness: double (medication in identical capsules). Duration: 4 weeks. Consent: written. Setting: multicentre, hospital. | |
Participants | Diagnosis: schizophenia (DSM‐III‐R). N=62. Sex: 38M, 24F. Age: 16‐63 years, mean ˜ 34 years. History: hospitalised, currently experiencing acute exacerbation. Exclusions: schizo‐affective or severe somatic disorders, pregnant or nursing women, substance abuse, abnormal lab results, long‐acting antipsychotic within 4 weeks of trial or short‐acting antipsychotics within 48 hours of trial. | |
Interventions | 1. Risperidone: 4‐12mg/day, initial dose of 4mg/day adjusted as required every 2 days. N=21.
2. Haloperidol: 4‐12mg/day, initial dose of 4 mg/day adjusted as required every 2 days. N=20.
3. Methotrimeprazine: 50‐150mg/day, initial dose of 50mg/day adjusted as required every 2 days. N=21*. loprazolam, diazepam, heptaminol hydrochloride as required. |
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Outcomes | Clinical improvement: 20% reduction in PANSS score.
Global effect: CGI improved/not improved, CGI score.
Mental state: PANSS, PANSS‐derived BPRS, PAS.
Behaviour: use of sedative medication.
Side effects: Asberg Scale, ESRS.
Leaving the study early. Unable to use ‐ Physiological monitoring: ECG, lab tests (insufficient data). |
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Notes | * Methotimeprazine data not used in this review. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |