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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: eight weeks.
Design: parallel.
Location: multicentre.
Participants Diagnosis: (DSM-III-R) schizophrenia (n=260) or schizoaffective disorder (n=36), acute exacerbation, PANSS total score of ≥60.
N=296.
Age: 18-64 years.
Gender: 215 M, 81 F.
History: duration of illness not reported, age at onset mean risperidone=24.6 years, mean ziprasidone=25.2 years.
Setting: not reported.
Interventions
  1. Risperidone: flexible dose, allowed dose range: 6-10 mg/day, mean dose=7.4 mg/day. N=147.

  2. Ziprasidone: flexible dose, allowed dose range: 80-160 mg/day, mean dose=114.2 mg/day. N=149

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global State: CGI.
Mental State: PANSS total score, PANSS derived BPRS, BPRS positive subscore, PANSS negative subscore, depression MADRS.
General functioning: GAF.
Adverse effects: open interviews, EPS (akathisia, tremor, use of antiparkinson medication, AIMS, BAS, SAS), cardiac effects (ECG),
prolactin-associated side-effects, sedation, weight gain, laboratory (urine, blood chemistry)
Unable to use-
GAF total score (no usable data).
QTc abnormalities in ms (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 attrition rate was 33%. The last observation carried forward method was used to account for people leaving the study early. Data on study completers were also available
Selective reporting (reporting bias) High risk Reporting on secondary outcomes was incomplete.
Other bias High risk The study was sponsored by the manufacturer of ziprasidone.