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 |
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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 |
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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) |
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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 |