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. Author manuscript; available in PMC: 2014 Sep 16.
Published in final edited form as: Cochrane Database Syst Rev. 2009 Oct 7;(4):CD006627. doi: 10.1002/14651858.CD006627.pub2
Methods Allocation: random, no further details.
Blindness: double, no further details.
Duration: 18 weeks.
Design: parallel.
Location: not reported.
Participants Diagnosis: schizophrenia, non-response to or intolerance of three previous antipsychotic treatment trials.
N=146.
Age: mean clozapine=38.3 years, mean ziprasidone=41.6 years.
Gender: 101 M, 45 F.
History: duration of illness not reported, age at onset not reported.
Setting: not reported.
Interventions
  1. Clozapine: flexible dose, allowed dose range: 250-600 mg/day, mean dose=345.7 mg/day. N=73.

  2. Ziprasidone: flexible dose, allowed dose range: 80-160 mg/day, mean dose=130.4 mg/day. N=73

Outcomes Leaving the study early: any reason.
Global State: CGI.
Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore, depression Calgary depression scale for schizophrenia.
Adverse effects: cardiac effects (ECG), laboratory.
Unable to use-
PANSS positive, negative subscore (no data).
CGI (no data).
Laboratory parameters (no usable data).
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random, no further details.
Allocation concealment (selection bias) Unclear risk No further details.
Blinding (performance bias and detection bias)
Subjective outcomes
Unclear risk Double, no further details. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side-effects. This can be a problem for blinding
Blinding (performance bias and detection bias)
Objective outcomes
Low risk Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding
Incomplete outcome data (attrition bias)
All outcomes
High risk The overall attrition was 38.4%. Data on reasons for dropout were not available. The last observation carried forward method was used to account for people leaving the study early
Selective reporting (reporting bias) High risk Data were only presented as an abstract. Primary and secondary outcome data were reported incompletely
Other bias High risk The study was sponsored by the manufacturers of ziprasidone.