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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Nov 10;(11):CD006633. doi: 10.1002/14651858.CD006633.pub2
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
  1. Clozapine: flexible dose. Allowed dose range: 200-600 mg/day.Mean dose: 303.6 mg/day. N=90.

  2. Olanzapine: flexible dose. Allowed dose range: 15-25 mg/day. Mean dose: 20.5 mg/day. N=90

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.