Lurasidone 2016.

Study characteristics
Methods	Randomisation: computer‐generated randomisation scheme (1:1 ratio). Allocation: interactive voice/web response system. Blinding: double‐blind, identically‐matched placebo. Duration: 28 weeks. Design: parallel. Location: multi‐centre. Setting: n.i.
Participants	Diagnosis: Schizophrenia (DSM‐IV‐TR), stabilised on study drug (after experiencing an acute exacerbation) for at least 12 weeks before randomisation. 87% paranoid type, 8% undifferentiated type, 4.9% disorganised type. N = 285. Gender: 178 men, 107 women. Age: 42,7 years. History: duration stable‐ at least 12 weeks, duration ill‐ 17,1 years, number of previous hospitalisations‐ 74% of the participants had at least 1 prior hospitalisation, 50% had four or more prior hospitalisations for schizophrenia, number of psychotic exacerbations in the previous 2 years‐ 1.8, age at onset‐ 23.7 years, severity of illness‐ mean PANSS total score 54.4, mean CGI‐S total score 2.72, baseline antipsychotic dose‐, remission at baseline‐ n.i..
Interventions	1. Drug: Lurasidone. N = 144 Flexible dose. Mean dose: 78.9 mg/day. Allowed dose range: 40 mg/day to 80 mg/day. 2. Placebo: duration of taper: no taper. N = 141. Rescue medication: anticholinergics (antiparkinson), benzodiazepines (insomnia, anxiety/agitation ‐ with restrictions). Limited use of psychotropic medications (including antipsychotics other than lurasidone) immediately prior to study discontinuation was permitted.
Outcomes	Examined Relapse (rating scale based and/or clinical judgement and/or need for hospitalisation or increase in the level of psychiatric care). Leaving the study early (any cause,adverse events, inefficacy). Service use ‐ Number of participants hospitalised. Participants´satisfaction with care: Health Economics Exit Questionnaire. Quality of life: EuroQol 5 Dimensions, Visual Analog Scale (EQ‐VAS). Social functioning: Specific Levels of Functioning, modified. Adverse effects. Death. Suicidal ideation and behaviour: Columbia Suicide Severity Rating Scale. Unable to use/Not included Global state: CGI‐S change scores (no usable data). Mental state: Positive and Negative Syndrome Scale total score and subscores (no predefined outcomes of interest). Depressive symptoms: Montgomery Asberg Depression Rating Scale (no predefined outcome of interest). Compliance to treatment: Brief Adherence Rating Scale (no predefined outcome of interest). Service use: Health Services Utilization Questionnaire (no usable data). Quality of life: Short Form‐12v2 Health Survey (SF‐12) (no usable data, available only for the Physical Component score, subscore of the scale. Chose the EuroQol data over these data) Smoking attitude (no predefined outcome of interest).
Notes	Sponsored by Sunovion, Takeda.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random sequence generation,
Allocation concealment (selection bias)	Low risk	Interactive Voice/Web Response System.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double‐blind, identically‐matched placebo.
Blinding (performance bias and detection bias) Subjective outcomes	Unclear risk	Double‐blind, identically‐matched placebo.
Blinding (performance bias and detection bias) Objective outcomes	Low risk	Double‐blind, identically‐matched placebo.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The overall attrition rate (54%) was high, substantially similar between the two groups. Only slightly more participants in the placebo group left the study early due to inefficacy/relapse. The primary efficacy outcome (relapse) was assessed using the Kaplan‐Meier survival curve analysis. Data for secondary outcomes were all analysed on an ITT basis (MMRM).
Selective reporting (reporting bias)	Unclear risk	Many secondary efficacy outcomes (but not the primary outcome) are reported incompletely so that they could not be entered in a meta‐analysis.
Other bias	Unclear risk	Following the end of the subject’s participation in the study, the PI or an authorized delegate had to report SAEs.