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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, double-dummy protocol.
Duration: 29 weeks.
Design: parallel.
Location: multicentre.
Participants Diagnosis: (DSM-IV) schizophrenia (n = 93) or schizoaffective disorder (n = 14), treatment resistance, moderate severity score on BPRS or SANS.
N = 107.
Sex: 84 M, 23 F.
Age: 18-60 years (mean = 42 years).
History: duration ill n.i., age at onset mean clozapine = 23 years, mean risperidone = 22 years.
Setting: in- and outpatient.
Interventions
  1. Clozapine: flexible dose. Allowed dose range: 500-800 mg/day. Mean dose: 456.7 mg/day. N= 53.

  2. Risperidone: flexible dose. Allowed dose range: 6-16 mg/day. Mean dose: 6.8 mg/day. N = 54

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global State: CGI.
General Mental State: BPRS total score, SANS.
Cognitive functioning: Spatial working memory performance, social skill and problem solving assessment.
Adverse effects: TESS, laboratory (hematology).
Unable to use:
SANS (modified version).
Notes
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, double-dummy protocol. 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?
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 63.9%. The analysis was based on mixed effect models, but it is unclear whether any statistical method can account for such a high dropout rate
Free of selective reporting? High risk Outcome reporting was incomplete. Quote: “…adverse events data have been reported elsewhere (unpublished study of N.R. Schooler et al.)
Free of other bias? Low risk Review authors did not find other sources of bias. Probably yes