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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jan 19;(1):CD006626. doi: 10.1002/14651858.CD006626.pub2
Methods Allocation: random, 2 steps of randomisation before and after availability of ziprasidone, subjects received other medication than in previous phase 1 treatment. Re-randomised.
Blindness: double, identical capsules.
Duration: 26 weeks.
Design: parallel.
Location: not reported.
Participants Diagnosis: (DSM-IV) chronic schizophrenia.
N = 444.
Sex: 308 M, 136 F.
Age: 18-65 years (mean olanzapine = 40.0 years, mean quetiapine = 40.1 years, mean risperidone = 41.8 years, mean ziprasidone = 41.3 years).
History: duration ill not reported, age at onset not reported.
Setting: in- and outpatient.
Interventions
  1. Olanzapine: flexible dose, allowed dose range: 7.5-30 mg/day, mean dose = 20.5 mg/day. N = 108.

  2. Quetiapine: flexible dose, allowed dose range: 200-800 mg/day, mean dose = 565.2 mg/day. N = 95.

  3. Risperidone: flexible dose, allowed dose range: 1.5-6.0 mg/day, mean dose = 4.1 mg/day. N = 104.

  4. Ziprasidone: flexible dose, allowed dose range: 40-160 mg/day, mean dose = 115.9 mg/day. N = 137

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global State: CGI.
Mental State: PANSS total score.
Adverse effects: open interviews, death (suicide), EPS (akathisia), cardiac effects (ECG), prolactin-associated side effects, weight gain, laboratory (prolactin, glucose, cholesterol)
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Adequate sequence generation? Unclear risk Random, 2 steps of randomisation before and after availability of ziprasidone, subjects received other medication than in previous phase 1 treatment. Re-randomised
Allocation concealment? Unclear risk No further details.
Blinding?
subjective outcomes
Unclear risk Double, identical capsules. Whether blinding was successful has not been examined, but both compounds differ quite substantially in side effects. This can be a problem for blinding
Blinding?
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 addressed?
All outcomes
High risk The overall attrition was high (72.5%). The main statistical analysis used a mixed effects model approach. It is unclear whether any statistical method can account for such high rates of leaving the study early
Free of selective reporting? High risk Use of antiparkinson medication was permitted but data on this outcome have not been presented
Free of other bias? Unclear risk Patients had a history of former intolerance to atypical antipsychotic treatment but baseline data on this was not provided