Methods | Allocation: randomised (individually numbered containers of medicines). Blindness: double-blind. Duration: 6 weeks. Setting: multi-centre. |
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Participants | Diagnosis: DSM schizophrenia (50% first episode). N=463. Age: 16-45 years, mean ~ 28 years. Sex: male and female (proportions not given). History: acute, 60% first hospitalisation, no significant hospitalisation 12 months prior to current admission |
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Interventions | 1. Chlorpromazine: dose range 200-1200 mg/day. N=112. 2. Fluphenazine: dose range 2-16 mg/day. N=115. 3. Thioridazine: dose range 200-1600 mg/day. n=111. 4. Placebo. 2-16 doses. N=125. Plus antiparkinsonian medication as needed for extrapyramidal side effects |
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Outcomes | Leaving the study early. Adverse effects. Unable to use. Global state: Global rating of severity of illness, improved/not improved -no usable data. Inpatient Multidimensional Psychiatric Scale (IMPS) - no usable data. Ward Behaviour Rating Scale (WBRS) - no usable data. |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised - no further details. |
Allocation concealment (selection bias) | Low risk | Individually numbered containers of medicines. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Double blind, untested. |
Incomplete outcome data (attrition bias) All outcomes |
High risk | Study attrition reported (not addressed in analysis). |
Selective reporting (reporting bias) | Unclear risk | No details. |
Other bias | Unclear risk | No details. |