Maridav/Adobe StockNew phase 3 study data on lumateprone (Caplyta) as adjunctive therapy for patients with major depressive disorder and anxious distress has reached primary and secondary endpoints. Inadequate response to antidepressant therapy was defined as less than 50% improvement with antidepressant monotherapy for 6 or more weeks, as measured by the Antidepressant Treatment Response Questionnaire. Patient population included 481 participants in the modified intent to treat group, with 207 (43%) having anxious distress at baseline. Patients were randomly assigned to 6-week oral administration of lumateperone 42 mg in combination with antidepressant therapy or to placebo plus antidepressant therapy. Lumateperone as adjunctive therapy in patients with major depressive disorder and anxious distress.