Efficacy and Safety of Lumateperone compared to Quetiapine in Indian patients with Bipolar II depression: A subgroup analysis based on mixed symptoms

Introduction Lumateperone, an atypical antipsychotic drug approved for Bipolar II depression in 2021, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors. Objectives This subgroup analysis of an Indian Phase 3 study was conducted to evaluate the efficacy and safety of Lumateperone 42mg compared to Quetiapine 300mg in treatment of Bipolar II depression when stratified based on mixed symptoms assessed via Young Mania Rating Scale (YMRS). Methods The phase-III, randomized, multi-centric, assessor-blind, parallel-group, active-controlled, comparative, non-inferiority study included patients with Bipolar II depression with moderate severity having a Montgomery-Asberg depression rating scale (MADRS) score ≥20 and Clinical global impression–bipolar version–severity (CGI-BP-S) score ≥4. The study was conducted after receiving regulatory and…