Methods | Allocation: randomised. Blindness: double. Duration: 18 weeks. |
|
Participants | Diagnosis: (DSM-IV) schizophrenia catatonic (N=3), disorganised (N=34), paranoid (N=101), residual (N=8) or undifferentiated (N=34), previous treatment resistance. N=180 Age: 18-70 years (mean=38.6 years). Gender: 115 M, 65 F. Setting: in- and outpatient. History: duration ill not reported, age at onset mean=22.8 years |
|
Interventions |
|
|
Outcomes | Leaving the study early: any reason, adverse events, inefficacy. Mental state: clinical improvement (at least 20%BPRS reduction+CGI-S<3 or BPRS<35) ( > or = 50% reduction on PANSS total), PANSS total, positive and negative subscore, BPRS total score. Adverse effects:extrapyramidal effects (SAS, AIMS, BAS), prolactin levels, weight change |
|
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Quote: “patients were randomly allocated in a 1:1 ratio to treatment with olanzapine 15-25 mg/day or clozapine 200-600 mg/day” Comment: Incomplete information. |
Allocation concealment? | No | No information. Probably not done. |
Blinding? All outcomes |
Yes | Quote: “An 18-week double-blind therapy” Comment: Probably done. The success of blinding was not evaluated |
Incomplete outcome data addressed? All outcomes |
No | 37/90 missing from clozapine and 36/90 missing from olanzapine Quote: “All end point analyses used a last observation carried forward (LOCF) algorithm” Comment: OC technique for weekly measures of patients with at least one post-baseline measurement. ITT analysis was not performed |
Free of selective reporting? | No | Spontaneously Reported Treatment-Emergent Adverse Events with an Incidence of ≥5% in either Treatment Group, or with a statistically significant difference (P< .05) between treatment Groups. Solicited treatment-emergent adverse events with statistically significant difference |
Free of other bias? | Yes | Review authors have not found other sources of bias. |