Effect of Lumateperone (ITI-007) on Quality of Life and Functional Disability in the Treatment of Bipolar Depression

Abstract: Background: Lumateperone is an FDA-approved antipsychotic to treat schizophrenia and depressive episodes associated with bipolar I or bipolar II disorder. In a Phase 3 clinical trial (Study 404, NCT03249376) in people with bipolar depression, lumateperone monotherapy significantly improved symptoms of depression compared with placebo. This analysis investigated improvements in functional disability and quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) individual items. Methods: Patients (18-75 years) with bipolar I or II disorder experiencing a major depressive episode (Montgomery-Åsberg Depression Rating Scale [MADRS] Total score≥20, Clinical Global Impression Scale-Bipolar Version-Severity score≥4) were randomized to lumateperone 42mg or placebo orally, once-daily in the evening for 6 weeks. This post hoc analysis evaluated mean change from baseline to Day 43 and categorical shifts in Q-LES-Q-SF individual item scores. Results: In the intent-to-treat population (n=376), lumateperone 42mg significantly improved MADRS Total score (least squares mean difference vs placebo [LSMD]=−4.585; P+0.3,) were seen in items representing the ability to function in daily life (+0.34), family relationships (+0.32), household activities (+0.31), leisure time activities (+0.34), and mood (+0.35)(all LSMD=0.3; all PShort Description: This post hoc analysis of a Phase 3 clinical trial investigated improvements in functional disability and quality of life with 6 weeks lumateperone 42mg treatment in patients with bipolar I or II disorder experiencing a major depressive episode. Compared with placebo, lumateperone significantly improved overall life satisfaction and 8 of 14 Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) individual items, reflecting significant improvement in patient quality of life.Name of Sponsoring Organization(s): Intra-Cellular Therapies, Inc.