Effectiveness studies of therapeutic switching of antipsychotics provide valuable clinical information.

Assess effectiveness of switching patients to lurasidone.

To evaluate 3 dosing strategies when switching patients to lurasidone.

Patients were randomized to three open-label lurasidone dosing strategies: 40mg/day for 14 days (n=74); 40mg/day for 7 days then 80mg/day for 7 days (n=88); and 80mg/day for 14 days (n=82) and stratified by their previous treatment (sedating vs non-sedating). Prior antipsychotic was tapered (50% step-down, day 8, discontinued day 14), followed by 4 weeks of flexible dose treatment (40-120 mg/day). Primary outcome was time to treatment failure (TTF). Of the 198 subjects completing core 6-week study, 149 (75.3%) enrolled in a 6-month extension study.

Switching to lurasidone was well tolerated; 198 (81.1%) of subjects completed core study, 19 (7.9%) subjects experienced treatment failure of which 16 (6.7%) discontinued due to an AE. No clinically relevant differences were noted among the 3 dosing strategies. TTF was earlier in patients previously receiving sedating antipsychotics vs. non-sedating (log rank p=0.101). Core study yielded LS mean (SE) within-group improvement on PANSS total score -5.3 (±0.7), LOCF with further improvement of -1.5 (±0.9), LOCF, at Month 6 from extension baseline. Ninety-eight subjects (65.8%) completed extension phase. Premature discontinuation causes included consent withdrawal (12.1%) and AEs (11.4%). Weight and lipid changes at 6 months were minimal.

Switching to lurasidone was safe and well tolerated regardless of initial dosing strategy. Switched patients maintained or improved symptom control during core and extension treatment.