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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, no further details.
Blindness: double, identical capsules.
Duration: 78 weeks.
Design: parallel.
Location: multicentre.
Participants Diagnosis: (DSM-IV) schizophrenia, previously more than one schizophrenic episode, responder.
N = 1493.
Age: 18-65 years (mean = 40.6 years).
Sex: 1080 M, 380 F.
History: duration 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=20.1 mg/day. N = 336.

  2. Perphenazine: flexible dose, allowed dose range: 8-32 mg/day, mean dose=20.8 mg/day. N = 261.

  3. Quetiapine: flexible dose, allowed dose range: 200-800 mg/day, mean dose=543.4 mg/day. N = 337.

  4. Risperidone: flexible dose, allowed dose range: 1.5-6.0 mg/day, mean dose=3.9 mg/day. N = 341.

  5. Ziprasidone: flexible dose, allowed dose range: 40-160 mg/day, mean dose=112.8 mg/day. N = 185

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global State: CGI-S.
Mental State: PANSS total score.
Service use: number of patients re-hospitalised.
Death: suicide attempt.
Adverse effects: open interviews, EPS (use of antiparkinson medication, akathisia), cardiac effects (ECG), prolactin-associated side effects, sedation, weight gain, laboratory (prolactin, lipids, glucose)
Unable to use:
Withdrawal due to “extrapyramidal effects” (no usable data).
Notes Note: 33 patients were excluded before analysis.
Risk of bias
Bias Authors’ judgement Support for judgement
Adequate sequence generation? Unclear risk Random, no further details.
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 (75%), and it is unclear whether any statistical method can account for such a high drop-out rate. Efficacy outcomes were evaluated based on mixed effects model analysis
Free of selective reporting? Low risk There was no evidence for selective reporting.
Free of other bias? Unclear risk Dose ranges were quite different, the upper dose range of olanzapine was 30 mg whereas risperidone could only be titrated up to 6mg /day. There was no wash-out period. An overlap in the administration of formerly given antipsychotics was permitted for the first four weeks after randomisation. Allocation to ziprasidone treatment was not possible from the start of the study due to the later availability of ziprasidone