Objectives: To evaluate the tolerability and effectiveness of switching stable patients with schizoaffective disorder to lurasidone utilizing three different switch strategies.
Methods: Non-acute patients with schizophrenia or schizoaffective disorder who were candidates for therapeutic switching from their current antipsychotic were randomized to three 6-week, open-label lurasidone switch strategies: a 40/40 group (N=74) started on 40 mg/d for 14 days; a 40/80 group (N=88) started on 40 mg/d for 7 days, then increased to 80 mg/d for 7 days; and an 80/80 group (N=82) with 80 mg/d for 14 days. All patients were then treated for 4 weeks with flexible doses of lurasidone (40-120 mg/d). Time to treatment failure was evaluated as the primary outcome.
Results: 37% of patients (n=91) met DSM-IV-TR criteria for schizoaffective disorder. Upon switching to lurasidone 6.6% (6 patients) discontinued due to adverse events. No clinically meaningful differences in completion rates were observed between the three initial dosing strategies. Two patients experienced treatment failure in each group. The five most commonly reported adverse events in patients with schizoaffective disorder were nausea (22.5%), insomnia (14.6%), akathisia (12.4%), vomiting (10.1%), and headache (9.0%). The mean PANSS total score at baseline in the schizoaffective disorder population was 72.1, with an LS Mean change at Week 6 of -6.3 (95% CI: -8.1; -4.5; LOCF).
Conclusions: Lurasidone was effective and well-tolerated in stable patients with a diagnosis of schizoaffective disorder who were switched from other antipsychotic agents. Study completion rates and treatment failure rates were similar across the three switch strategies.