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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: single, rater-blinded.
Duration: 16 weeks.
Design: parallel.
Location: multicentre.
Participants Diagnosis: (DSM-IV) first episode schizophrenia (n = 84), schizophreniform disorder (n = 19) or schizoaffective disorder (n = 9) (of intent-to-treat population).
N = 120.
Sex: 78 M, 34 F (of intent-to-treat population).
Age: 16-40 years (mean = 23.3 years) (of intent-to-treat population).
History: duration ill mean = 2.2 years (of intent-to-treat population), age at onset mean = 20.7 years (of intent-to-treat population).
Setting: not reported.
Interventions
  1. Olanzapine: flexible dose. Allowed dose range: 2.5-20 mg/day. Mean dose: 11.8 mg/day. N = 60.

  2. Risperidone: flexible dose. Allowed dose range: 1-6 mg/day. Mean dose: 3.9 mg/day. N = 60

Outcomes Leaving the study early: inefficacy.
Global State.
Adverse effects: EPS (parkinsonism, use of antiparkinson medication, Simpson-Angus) , weight gain
Unable to use:
Leaving the study early: incomplete data.
Weight gain: no 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 Single-blind, rater-blinded. 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 possibly acceptable (28%), but data on leaving the study early were incompletely reported. Eight patients were excluded from the analysis for various reasons. The statistical analysis was based on mixed model approach
Free of selective reporting? High risk Data on the general mental state (PANSS total score) were not presented. The data available for adverse effects were incomplete. Data on weight gain were missing
Free of other bias? Unclear risk Quote: “.. the study was designed to detect differences in our primary analysis at alpha = 0.05 with 80% power based upon 130 subjects, the stability analysis included only 47 subjects and therefore might lack adequate power.”