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. 2018 May 11;2018(5):CD011883. doi: 10.1002/14651858.CD011883.pub2

Loebel 2014.

Methods Randomisation: randomised, no further details
 Blinding: double, no further details
 Duration: 6 weeks; 2 weeks double‐blind run in phase and 4 weeks randomised double‐blind phase
 Design: parallel
 Location: multi‐centre
 Setting: inpatients
Participants Diagnosis: acute schizophrenia, no further details
N = 95
 Gender: 60.1% males (of initially randomised participants to lurasidone 80 mg/day) (N = 198)
 Age: mean 40.5 years; range 18 to 75 years for all initially randomised participants to lurasidone 80 mg/day
History: no details
Interventions Participants were firstly randomised to double‐blind treatment with lurasidone 20 mg/day, lurasidone 80 mg/day, or placebo. After 2 weeks, only participants who were randomised to lurasidone 80 mg/day (N = 198) and showed < 20% PANSS total score reduction, were re‐randomised to either:
1. dose increase: lurasidone 160 mg/day. N = 43; or
2. dose maintenance: lurasidone 80 mg/day. N = 52.
Rescue medication: no details
Outcomes Leaving the study early: due to side effects
Mental state: general (PANSS total score)
Global state (CGI‐Severity change)
Unable to use:
Weight gain (not separately presented for the two groups)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Eligible patients were randomised to..." (pg. 476); no further details
Allocation concealment (selection bias) Unclear risk No details are presented
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "...to double‐blind treatment with..." (pg. 476); no further details
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "...to double‐blind treatment with..." (pg. 476); no further details
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Outcome not addressed
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Low risk No obvious risk for other bias