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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, no further details.
Duration: 8 weeks.
Design: parallel.
Location: multicenter.
Participants Diagnosis: (DSM-III-R) chronic schizophrenia, non-responders or intolerance, PANSS between 60 and 120.
N = 86.
Sex: 61 M, 25 F.
Age: 18-65 years (mean = 37.3).
History: age at first hospitalisation mean clozapine = 25.0, mean risperidone = 26.0, age at onset mean clozapine = 23.5, mean risperidone = 22.4.
Setting: inpatient.
Interventions
  1. Clozapine: flexible dose. Allowed dose range: 150-400 mg/day. Mean dose: 291.2 mg/day. N = 43.

  2. Risperidone: flexible dose. Allowed dose range: 3-10 mg/day. Mean dose: 6.4 mg/day. N = 43

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore).
Adverse effects: cardiac effects, EPS (akinesia, dystonia, parkinsonism, use ofantiparkin-son medication), prolactin associated side effects (sexual dysfunction), sedation, failing memory, concentration difficulties, nausea, weight gain, laboratory (hematology)
Unable to use:
Change of weight in kg (no usable data).
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, 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?
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
Unclear risk The overall attrition was moderate (20.9%) . The LOCF method was used to account for people leaving the study early. It assumes that a participant who discontinued the study would not have had a change of his condition if he had remained in the study. This assumption can obviously be wrong
Free of selective reporting? High risk Secondary outcomes were not fully reported. For treatment emergent adverse events there was an incidence ofat lest 5% occurrence for being reported
Free of other bias? High risk The study was sponsored by the manufacturer of risperidone.