Methods | Allocation: randomised. Blindness: double. Duration: 6 weeks. |
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Participants | Diagnosis:(DSM-III-R) schizophrenia catatonic, hebephrenic, paranoid or residual. N=50. Age: 18-60 years. Gender: not reported. History: BPRS >40 after washout phase, no previous treatment with either medication |
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Interventions |
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Outcomes | Leaving the study early: any reason. Unable to use: CGI, BPRS, SANS, adverse events: ECG, weight gain (matched samples) |
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Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Quote: “They were randomly assigned..” Comment: Incomplete information. |
Allocation concealment? | No | Probably not done. |
Blinding? All outcomes |
Yes | Quote: “They were randomly assigned in a double design to clozapine or zotepine” Comment: Probably done. The success of blinding was not evaluated |
Incomplete outcome data addressed? All outcomes |
No | 7/25 missing from clozapine and 10/25 missing from zotepine. ITT was not performed |
Free of selective reporting? | No | Quote: “Analysis refers to a sub-sample of 26 patients, (matched for age).” Comment: Data from sub sample was not used in our review. |
Free of other bias? | Unclear | Quote: “This study was sponsored and monitored by Klinge Pharma (manufacturer of zotepine)” |