Methods | Allocation: randomised. Blindness: double. Duration: four weeks. |
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Participants | Diagnosis:(ICD-9) acute schizophrenia, disorganised, catatonic, paranoid, unspecified type. Schizoaffective psychosis, schizodominant type. N=59. Age: 19-65 years. Gender: 31 M, 28 F. Setting: not reported. History: duration ill not reported, age at onset not reported |
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Interventions |
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Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Global state: CGI. Mental state: BPRS total score, BPRS subscore. Adverse effects: at least one adverse effect, cardiac effects (pre terminal negative T-wave), extrapyramidal side-effects (extrapyramidal symptoms, use ofantiparkinson medication, Simpson-Angus Scale), sedation. Unable to use: White blood cell count: agranulocytosis (no data). |
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Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Quote: “This is a randomised, double blind study..” Comment: Incomplete information. |
Allocation concealment? | No | No information. Probably not done. |
Blinding? All outcomes |
Yes | Quote: “This is a randomised, double blind study..” Tablets were identical appearance. Comment: Probably done. The success of blinding was not evaluated |
Incomplete outcome data addressed? All outcomes |
Yes | 6/20 missing from clozapine, 13/19 from risperidone 8 mg and 9/20 from risperi-done 4 mg. Intention to treat analyses and LOCF |
Free of selective reporting? | No | There was incomplete information about some adverse events as body weight, blood pressure, ECG Adverse events considered only the most frequent spontaneously reported adverse experience |
Free of other bias? | Yes | Review authors have not found other sources of bias. |