OBJECTIVES: Estimates of efficacy and safety are required for economic models developed for health technology assessments and provide guidance to decision-makers regarding the benefit/risk profile of a drug. Studies synthesising clinical trial outcomes of atypical antipsychotics in schizophrenia often assume no dose-related heterogeneity. The objective of this analysis was to assess dose-related efficacy and weight changes after 6 weeks of treatment with lurasidone, an atypical antipsychotic indicated for treatment of schizophrenia at an effective dose range of 20 mg to 160 mg/day. METHODS: Random-effects meta-analysis was used to synthesize evidence from five, 6-week, randomized, double-blind, placebo-controlled studies of lurasidone in patients with acute schizophrenia. Outcome measures included 6-week changes in Positive And Negative Syndrome Scale (PANSS) total score and weight (in kg). Results were pooled within and across the daily dose range (40-160 mg/day) studied in these trials. RESULTS: Pooled mean difference in PANSS total score was -8.38 (95% CI: -11.19, -5.56); and in weight was 0.51 kg (95% CI: 0.28, 0.75). Between-dose heterogeneity (I-squared=61.2%, p=0.006) was introduced by the 160 mg dose, which was associated with greater treatment effect (mean difference -16.20; 95% CI: -21.10, -13.30). Moderate between-study heterogeneity was observed in the 40 mg and 120 mg doses (I-squared values were 52.8% and 33.2%, respectively). There was no evidence of between-dose or between-study heterogeneity in weight gain. CONCLUSIONS: Changes in PANSS total score from this meta-analysis suggest that lurasidone in the daily dose range of 40-120 mg had similar efficacy versus placebo. The 160 mg daily dose was associated with greater reduction in PANSS total score versus placebo; however, this finding was based on evidence from a single study. This analysis found no evidence of a dose-related weight gain.