Methods | Allocation: randomised. Blindness: double. Duration: 8 weeks. |
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Participants | Diagnosis: (DSM-IV) schizophrenia, treatment resistance to two previous antipsychotic medications, BPRS score of 27 or more. N=23. Age: 18 years or more (mean clozapine=38.3 years, mean olanzapine=34.1 years) (of completer population). Gender: 16 M, 7 F. Setting: inpatient. 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. Mental state: PANSS total score, BPRS total score, PANSS positive and negative sub-score. Adverse effects: at least one adverse effect, extrapyramidal side effects (SAS) Unable to use: AIMS (no useable data) |
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Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Quote: “Before randomisation..” Comment: Information incomplete. |
Allocation concealment? | No | Probably not done. |
Blinding? All outcomes |
Yes | Quote:“ A double blind, parallel study.” Comment: Probably done. The success of blinding was not evaluated |
Incomplete outcome data addressed? All outcomes |
No | 6/12 missing from clozapine and 2/11 missing from olanzapine ITT not performed. |
Free of selective reporting? | Unclear | No information about form to assess the adverse events. |
Free of other bias? | Unclear | Quote: “Study was partially supported by Eli-Lilly” |