Downing 2014.

Methods	Allocation: multicenter, randomised. Blindness: double blind; Quote: 'the raters were blind to the study design, entrance criteria, and patient treatment assignment.' p.3) Duration: 2 weeks study entry + 7 days placebo lead‐in treatment phrase + 6 weeks treatment duration. Settings: inpatients. Design: parallel.
Participants	Diagnosis: schizophrenia (historical documentation and Structured Clinical Interview for DSM‐IV Disorders [SCID] interview). N = 1009. (1013 participants were randomised, however, the author analysed data on an Intention‐to‐treat basis) Age: mean ˜ 39.8 years, SD ˜ 11.4 years. Sex: male 647, female 362. Length of illness: mean ˜ 14.5 years, SD ˜ 10.7 years. Inclusion criteria: those with an accurate and reliable diagnosis of schizophrenia (based upon historical documentation and Structured Clinical Interview for DSMIV Disorders [SCID] interview), who experienced an exacerbation of their illness 2 weeks prior to study entry (Visit 1), leading to a need for intensification of psychiatric care. Patients could be antipsychotic treatment naive or have had prior exposure to antipsychotic medications and were not treatment refractory in the opinion of the investigator. Exclusion criteria: those who had any other current Axis I psychiatric diagnoses in addition to schizophrenia, a diagnosis of substance dependence or substance abuse, a history of one or more seizures, answered yes to any suiciderelated behaviors within 1 month of Visit 1, participated in any clinical trial for which they received a studyrelated medication in the 6 months prior to Visit 1, were treatment refractory, or had demonstrated an inadequate response to treatment with risperidone, or for whom treatment with risperidone, LY2140023, or placebo was contraindicated.
Interventions	1. Risperidone: 2 mg/d on the first day and 4mg/d therafter, N = 142. 2. Placebo: placebo tablets or capsules identical to LY2140023 and risperidone, N = 295. 3. LY2140023 low dose: twice daily, 40 mg/d, N = 292*. 4. LY2140023 high dose: twice daily, 80 mg/d, N = 280*.
Outcomes	Leaving the study early. Adverse effects**. Unable to use Mental state: PANSS (only means of change score were reported).
Notes	*We did not use the data from these groups, as the interventions are not relevant. **For the concomitant medications rate reported in this study, we only extracted 2 drugs mentioned in our protocol.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised, no further information. Quote: "multicenter, randomized, doubleblind, parallel..." (p.2).
Allocation concealment (selection bias)	Unclear risk	No information available.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: 'the raters were blind to the study design, entrance criteria, and patient treatment assignment.' (p.3)
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis was performed.
Selective reporting (reporting bias)	Low risk	All the measured outcomes were reported.
Other bias	High risk	All authors were from Eli Lilly and Company.